Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-30 @ 1:06 AM
Study NCT ID:
NCT00659061
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2008-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring and Evaluation of Micronutrients (Sprinkles) Project
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zulfiqar.bhutta@aku.edu', 'phone': '4930051', 'title': 'Professor Zulfiqar Ahmed Bhutta', 'phoneExt': '4782', 'organization': 'Aga Khan University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The attrition rate was high (6.8% in intervention group and 5.0% in the control group) due to unforeseen migration because of political unrest in the region.'}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Anemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sprinkle-Advice', 'description': 'Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'OG001', 'title': 'Advice Only', 'description': 'Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}], 'classes': [{'title': 'Baseline anemia prevalence', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}]}, {'title': 'Endline anemia prevalence', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'at baseline', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'at endline', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment', 'description': 'number with mild to severe anemia (hemoglobin(Hb)\\<11g/dL)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vitamin A Status of Participants - Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sprinkle-Advice', 'description': 'Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'OG001', 'title': 'Advice Only', 'description': 'Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}], 'classes': [{'title': 'Low (<20 ug/dl)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}]}, {'title': 'Moderate (20-40 ug/dl)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'High (>40 ug/dl)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measurement taken 4-5 months post enrollment', 'description': 'Categorized as \\<20ug/dL; 20-40 ug/dL; \\>40 ug/dl', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'those who had endline assessment of serum vitamin A'}, {'type': 'SECONDARY', 'title': 'Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sprinkle-Advice', 'description': 'Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'OG001', 'title': 'Advice Only', 'description': 'Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '28.4', 'upperLimit': '35.2'}, {'value': '25.1', 'groupId': 'OG001', 'lowerLimit': '22.5', 'upperLimit': '27.8'}]}]}], 'analyses': [{'pValue': '<0.000', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for baseline, child age, sex, number of sprinkles sachets consumed, number of mths between enrollment and endline Hb measurement)'}], 'paramType': 'MEAN', 'timeFrame': 'Measurement taken 4-5 months post enrollment', 'unitOfMeasure': 'ug/dl', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Moderate to Severe Anemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sprinkle-Advice', 'description': 'Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'OG001', 'title': 'Advice Only', 'description': 'Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}, {'title': 'Endline', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'baseline', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'endline', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment', 'description': 'number of participants with moderate - severe anemia defined as Hb \\< 10g/dL', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Hemoglobin of Participants Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sprinkle-Advice', 'description': 'Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'OG001', 'title': 'Advice Only', 'description': 'Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.97', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '11.3'}, {'value': '9.98', 'groupId': 'OG001', 'lowerLimit': '9.7', 'upperLimit': '10.2'}]}]}], 'analyses': [{'pValue': '0.000', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'endline', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'adjusted for baseline child age, sex, # of sprinkle sachet consumed, # of mths between enrollment and endline Hb measurement'}], 'paramType': 'MEAN', 'timeFrame': 'Endline Hb taken 4-5 months post enrollment', 'unitOfMeasure': 'g/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Underweight Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sprinkle-Advice', 'description': 'Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'OG001', 'title': 'Advice Only', 'description': 'Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}], 'classes': [{'title': 'Baseline Underwt %', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Endline Underwt %', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'baseline', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'endline', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment', 'description': 'Underweight defined as Weight for Age Z score \\< -2 standard deviation (SD)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'those who had complete baseline anthropometric measures'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Stunted Growth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sprinkle-Advice', 'description': 'Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'OG001', 'title': 'Advice Only', 'description': 'Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}], 'classes': [{'title': 'Baseline Stunted %', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Endline Stunted %', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'baseline', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'endline', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment', 'description': 'Stunted defined as Height for Age Z-score \\< -2 standard deviation', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Those who had complete anthropometric measurements at endline'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Wasted Growth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sprinkle-Advice', 'description': 'Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'OG001', 'title': 'Advice Only', 'description': 'Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}], 'classes': [{'title': 'Baseline Wasted %', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Endline Wasted %', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'baseline', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'endline', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment', 'description': 'Wasted defined as Weight for Height Z-score \\< -2SD', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'those who had complete anthropometric measurements at endline'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sprinkle-Advice', 'description': 'Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'FG001', 'title': 'Advice Only', 'description': 'Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '308'}, {'groupId': 'FG001', 'numSubjects': '302'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Those with either complete or partial biochemical and anthropometric data', 'groupId': 'FG000', 'numSubjects': '287'}, {'comment': 'Those with either complete or partial biochemical and anthropometric data', 'groupId': 'FG001', 'numSubjects': '287'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Migration due to political unrest', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '610', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sprinkle-Advice', 'description': 'Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'BG001', 'title': 'Advice Only', 'description': 'Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '12.3', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '12.2', 'spread': '3.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 610}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2008-04-14', 'resultsFirstSubmitDate': '2008-12-15', 'studyFirstSubmitQcDate': '2008-04-14', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-04-02', 'studyFirstPostDateStruct': {'date': '2008-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Anemia', 'timeFrame': 'Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment', 'description': 'number with mild to severe anemia (hemoglobin(Hb)\\<11g/dL)'}, {'measure': 'Number of Participants With Moderate to Severe Anemia', 'timeFrame': 'Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment', 'description': 'number of participants with moderate - severe anemia defined as Hb \\< 10g/dL'}, {'measure': 'Mean Hemoglobin of Participants Post Intervention', 'timeFrame': 'Endline Hb taken 4-5 months post enrollment'}], 'secondaryOutcomes': [{'measure': 'Vitamin A Status of Participants - Post Intervention', 'timeFrame': 'Measurement taken 4-5 months post enrollment', 'description': 'Categorized as \\<20ug/dL; 20-40 ug/dL; \\>40 ug/dl'}, {'measure': 'Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention', 'timeFrame': 'Measurement taken 4-5 months post enrollment'}, {'measure': 'Percentage of Underweight Participants', 'timeFrame': 'Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment', 'description': 'Underweight defined as Weight for Age Z score \\< -2 standard deviation (SD)'}, {'measure': 'Percentage of Participants With Stunted Growth', 'timeFrame': 'Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment', 'description': 'Stunted defined as Height for Age Z-score \\< -2 standard deviation'}, {'measure': 'Percentage of Participants With Wasted Growth', 'timeFrame': 'Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment', 'description': 'Wasted defined as Weight for Height Z-score \\< -2SD'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['micronutrients'], 'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': "The purpose of this study is 1) to evaluate the effectiveness in reducing anemia among children 6-24 months of age by providing daily micronutrient Sprinkles through the Government of Pakistan's Lady Health Worker program; 2) to assist in the monitoring the National Sprinkles Pilot Project.", 'detailedDescription': 'According to the recent National Nutrition Survey in Pakistan (2001-2002), approximately 66.5% of children under five have anaemia.\n\nLooking at the magnitude of the problem, National Program for Family Planning (FP) and Primary Health Care (PHC) (also known as the Lady Health Workers (LHW) Program) has developed National Sprinkles Pilot Project Proposal with technical assistance of Micronutrient Initiative and Aga Khan University (AKU). As the projects technical partner, AKU is responsible to conduct the monitoring and evaluation of the project.\n\nThe study will use a cluster randomized pre-post intervention design that compares before and after hemoglobin (Hb) measurements, serum ferritin, serum retinol and urinary iodine among children who received Sprinkles and age-appropriate feeding advice (Sprinkles-Advice group) and children who only receive age-appropriate feeding advice (Advice-only group). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits. However, intervention LHWs, will give additional advice regarding the benefits of Sprinkles and its appropriate use.\n\nThe target population selected for the study consisted of children between the ages of six and eighteen months of age in the catchment area of the Lady Health Workers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child's mother gives written consent after hearing an explanation of the study\n* Random selection of child in household with more than one eligible child\n\nExclusion Criteria:\n\n* Any household in which consent is not given\n* Children with any congenital or physical disability (such as cleft palate, Down's Syndrome, etc.)\n* Child from a family which intends to migrate during the study period"}, 'identificationModule': {'nctId': 'NCT00659061', 'acronym': 'Sprinkles', 'briefTitle': 'Monitoring and Evaluation of Micronutrients (Sprinkles) Project', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Monitoring and Evaluation of Micronutrients (Sprinkles) Project', 'orgStudyIdInfo': {'id': '754-Ped/ERC-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Multiple micronutrient fortificant (Sprinkles) and nutrition education given by LHWs.', 'interventionNames': ['Dietary Supplement: SPRINKLES', 'Behavioral: Nutrition education']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Routine public health massages by Lady Health Workers (LHWs) during their community visits.'}], 'interventions': [{'name': 'SPRINKLES', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Multiple micronutrient fortificant'], 'description': 'Sprinkles is a multiple micronutrient fortificant. It is packed as a single serving sachets each containing micro encapsulated iron (12.5 mg), zinc (7.5 mg), vitamin C (30 mg), vitamin A (300 µg), vitamin D (5 µg), folic acid (150 µg) and iodine (90µg).\n\nTwo month supply of the Sprinkle sachet along with advice on its benefits as well as its appropriate use will be given by the LHWs. The LHWs will also provide their age-appropriate nutritional advice as per their regular door to door community services.', 'armGroupLabels': ['Intervention']}, {'name': 'Nutrition education', 'type': 'BEHAVIORAL', 'description': 'Nutrition education will be provided by LHWs as per their regular routine monthly door to door community services', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Naushero Feroze', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'AKU-Peds Naushero Feroze Site Office'}], 'overallOfficials': [{'name': 'Zulfiqar A Bhutta, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aga Khan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Micronutrient Initiative', 'class': 'OTHER'}, {'name': 'M/S SEBCON', 'class': 'OTHER'}, {'name': 'Pakistan Ministry of Health', 'class': 'OTHER_GOV'}, {'name': 'National Programme of Family Planning and Primary Health Care', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Founding Director, Centre of Excellence in Women and Child Health', 'investigatorFullName': 'Dr Zulfiqar Ahmed Bhutta', 'investigatorAffiliation': 'Aga Khan University'}}}}