Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-10 @ 3:45 PM
Study NCT ID:
NCT04404751
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2019-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quadruple Fortified Salt Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C034024', 'term': 'iodized salt'}, {'id': 'D007501', 'term': 'Iron'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-21', 'studyFirstSubmitDate': '2019-09-03', 'studyFirstSubmitQcDate': '2020-05-21', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemoglobin level', 'timeFrame': '10 months of consuming fortified salt', 'description': 'After 10months use of quadruple fortified salt we expect the HB to rise by at least 50% as compared to those who used iodised salt'}], 'secondaryOutcomes': [{'measure': 'Iron store replenishment', 'timeFrame': '10months of intervention', 'description': 'The quadruple fortified salt is expected to replenish the iron store 100% after 10 months use of QFS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': "Anaemia is the world leading cause of disability and is responsible for about more than 115,000 maternal deaths and 591,000 perinatal deaths per year, of which 3/4 occur in Africa and Asia. Despite the fact that there are several causes of anemia, the most important causes are due to micronutrients deficiency, namely iron, Folic acid and Vitamin B12. Low intakes of these micronutrients consequently affect a woman's health, pregnancy outcome and the nutritional status of breast-fed children. With these in mind we wish to test the effectiveness of salt fortified with these four micronutrients (Iodine, Iron, Folic acid and vitamin B12) in raising the Hemoglobin levels among the non-pregnant and non-lactating women of reproductive age.", 'detailedDescription': 'Anaemia is the low level of Haemoglobin based on the location. As per WHO a woman is termed anaemic if has HB \\<11g/dl but in high attitude is =\\<13g/dl'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult with relative low haemoglobin (Hb level 8g/dl to 13g/dl)\n* Able to eat food cooked with salt\n* Able to give consent\n\nExclusion Criteria:\n\n* Planning to become pregnant within the study period,\n* chronically ill,\n* have haematological diseases during study time,\n* restricted to use salt in food'}, 'identificationModule': {'nctId': 'NCT04404751', 'briefTitle': 'Quadruple Fortified Salt Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Haydom Lutheran Hospital'}, 'officialTitle': 'Effectiveness of Quadruple Fortified Salt in Improving Hemoglobin Levels Among Anemic Women of Reproductive Age (18-49 Years) in Rural Low Resource Setting', 'orgStudyIdInfo': {'id': 'Salt_HGHRC#01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'interventionNames': ['Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12']}, {'type': 'SHAM_COMPARATOR', 'label': 'Arm 3', 'interventionNames': ['Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12']}], 'interventions': [{'name': 'Iodised salt with Iron, Folic acid and Vitamin B12', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Iodised salt with Iron'], 'description': 'Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manyara', 'country': 'Tanzania', 'facility': 'Haydom Lutheran Hospital', 'geoPoint': {'lat': -3.6, 'lon': 35.93333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haydom Lutheran Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'Tanzania Food and Drugs Authority', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}