Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131222
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2005-08-16
Brief Title:
Trial to Alleviate Malnutrition With Fortified Spread Given as a Food Supplement to Underweight Infants
Sponsor:
Tampere University
Organization:
Tampere University
Study Overview
Official Title:
Lungwena Child Nutrition Intervention Study-4 LCNI-4 A Single-centre Intervention Trial in Rural Malawi Testing the Potency of RUTF Supplementation to Alleviate Moderate Malnutrition Among 6-17 Month Old Infants
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study tests the hypothesis that underweight 6-17-month old infants receiving fortified spread as a food supplement for 12 weeks grow better during the supplementation than infants who are provided with maize-soy flour supplement
Detailed Description:
Childhood undernutrition is very common in rural Malawi like in many other countries in Sub-Saharan Africa Usually undernutrition develops between 6 and 24 months of age By two years of age 30-50 of all children in rural Malawi are undernourished predisposing them to subsequent morbidity developmental delay and mortality Urgent interventions are needed but the magnitude of the problem precludes a hospital-based management strategy Therefore emphasis must be on prevention and early home-based rehabilitation of children with mild-to-moderate malnutrition However the options for community based approaches are not as developed as those for institutional management of undernutrition
The present study tests a recently developed nutrient -dense spread ready-to use- therapeutic food RUTF which offers a potential solution to home based nutrition rehabilitation The concept has previously been shown to work not only in therapeutic feeding of undernourished children in nutrition rehabilitation units in Malawi but also home based supplementation of undernourished children aged 42 to 60 months in Mangochi District southern Malawi In the present study the investigators will test the efficacy in growth promotion of this product when provided as a supplementary food to moderately underweight infants defined as WAZ -2 between 6 and 18 months of age
The study will be conducted in Lungwena area Mangochi District rural Malawi A total of 176 6-14 -month old infants will be enrolled and randomised to two groups receiving different daily food supplements for 12 weeks Children in group one control group will receive 72g of fortified maizesoy flour and children in group 2 will receive 50g RUTF daily The food supplements will be delivered to the participants home at 3-weekly intervals
All children will undergo medical and anthropometric examinations at 6-weekly intervals and disease symptoms monitoring every week Dietary intake assessments will be conducted at 3 and 9 weeks after the onset of supplementation A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations At enrolment childrens HIV status will be screened with antibody-ELISA and confirmed with HIV PCR
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the two intervention groups Secondary outcomes include length gain increase in tibial length and changes in blood haemoglobin and serum ferritin concentration The study will also produce descriptive data on morbidity and intake of foods during the intervention
The present study tests a recently developed nutrient -dense spread ready-to use- therapeutic food RUTF which offers a potential solution to home based nutrition rehabilitation The concept has previously been shown to work not only in therapeutic feeding of undernourished children in nutrition rehabilitation units in Malawi but also home based supplementation of undernourished children aged 42 to 60 months in Mangochi District southern Malawi In the present study the investigators will test the efficacy in growth promotion of this product when provided as a supplementary food to moderately underweight infants defined as WAZ -2 between 6 and 18 months of age
The study will be conducted in Lungwena area Mangochi District rural Malawi A total of 176 6-14 -month old infants will be enrolled and randomised to two groups receiving different daily food supplements for 12 weeks Children in group one control group will receive 72g of fortified maizesoy flour and children in group 2 will receive 50g RUTF daily The food supplements will be delivered to the participants home at 3-weekly intervals
All children will undergo medical and anthropometric examinations at 6-weekly intervals and disease symptoms monitoring every week Dietary intake assessments will be conducted at 3 and 9 weeks after the onset of supplementation A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations At enrolment childrens HIV status will be screened with antibody-ELISA and confirmed with HIV PCR
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the two intervention groups Secondary outcomes include length gain increase in tibial length and changes in blood haemoglobin and serum ferritin concentration The study will also produce descriptive data on morbidity and intake of foods during the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None