Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420758
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2007-01-10
Brief Title:
Effectiveness Trial on Alleviation of Infant Malnutrition With Fortified Spread or Maize-Soy Flour Food Supplements
Sponsor:
Tampere University
Organization:
Tampere University
Study Overview
Official Title:
LCNI-7 A Three-centre Intervention Trial in Rural Malawi Testing the Effectiveness of Fortified Spread or Maize-Soy Flour Supplementation to Alleviate Moderate Malnutrition Among 6-18 Month Old Children
Status:
COMPLETED
Status Verified Date:
2015-12
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 moderately underweight but not severely wasted 6-17-month old infants receiving fortified spread or maize-spy flour as a food supplement for 12 weeks grow better during the supplementation than infants who do not get any food 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 micronutrient fortified spread FS 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 but not wasted infants defined as WAZ -2 WHM80 between 6 and 18 months of age
The study will be conducted in Lungwena area Mangochi District rural Malawi A total of 291 6-15 -month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 weeks Children in group one control group will not receive any supplementation children in group two will receive 1200 g FS 4-weekly 43 g day and children in group 3 will received 2000 g of fortified maizesoy flour weekly 71 g day Participants guardians will collect the food supplements from a local health centre at 4-weekly intervals
All children will undergo medical and anthropometric examinations at the beginning and end of the 12-week follow-up period Dietary intake assessments will be conducted at 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 concentration
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups Secondary outcomes include length gain and changes in blood haemoglobin concentration The study will also produce descriptive data on intake of foods during the intervention
The present study tests a recently developed micronutrient fortified spread FS 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 but not wasted infants defined as WAZ -2 WHM80 between 6 and 18 months of age
The study will be conducted in Lungwena area Mangochi District rural Malawi A total of 291 6-15 -month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 weeks Children in group one control group will not receive any supplementation children in group two will receive 1200 g FS 4-weekly 43 g day and children in group 3 will received 2000 g of fortified maizesoy flour weekly 71 g day Participants guardians will collect the food supplements from a local health centre at 4-weekly intervals
All children will undergo medical and anthropometric examinations at the beginning and end of the 12-week follow-up period Dietary intake assessments will be conducted at 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 concentration
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups Secondary outcomes include length gain and changes in blood haemoglobin concentration The study will also produce descriptive data on 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