Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131209
Status:
COMPLETED
Last Update Posted:
2008-07-08
First Post:
2005-08-16
Brief Title:
Trial to Test the Growth-Promoting Effect of Fortified Spreads When Used as Complementary Food for Infants
Sponsor:
Tampere University
Organization:
Tampere University
Study Overview
Official Title:
Lungwena Child Nutrition Intervention Study 3 LCNI-3 A Single-Centre Intervention Trial in Rural Malawi Testing the Anthropometric and Health Benefits of Provision of Ready to - Use - Therapeutic Food RUTF as a Complementary Food
Status:
COMPLETED
Status Verified Date:
2008-07
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 infants receiving fortified spread as a complementary food for one year grow better and do not become malnourished as often as infants who are provided with maize-soy flour for complementary porridge
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 in Mangochi District southern Malawi In the present study the investigators will test the efficacy in growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age
The study will be conducted in Lungwena area Mangochi District rural Malawi A total of 180 6-month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 months Children in group-one control group will receive 75g of maizesoy flour daily Children in group-two will receive 25g RUTF daily and children in group-three will receive 50g RUTF daily for a period of 12 months The food supplements will be delivered to the participants home at weekly intervals
All children will undergo medical and anthropometric examinations at 4-monthly intervals and disease symptoms monitoring every week Dietary intake assessments will be conducted at 12 and 15 months of age A random sample of 36 children will undergo breast milk intake assessments before the start of food supplementation and during food supplementation A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations and test human immunodeficiency virus HIV at 6 and 18 months
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups Secondary outcomes include length gain incidence of moderate underweight stunting and wasting cognitive and motor development at the end of trial and changes in blood haemoglobin and serum ferritin concentration The study will also produce descriptive data on morbidity and intake of breast milk and other 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 in Mangochi District southern Malawi In the present study the investigators will test the efficacy in growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age
The study will be conducted in Lungwena area Mangochi District rural Malawi A total of 180 6-month old infants will be enrolled and randomised to three groups receiving different daily food supplements for 12 months Children in group-one control group will receive 75g of maizesoy flour daily Children in group-two will receive 25g RUTF daily and children in group-three will receive 50g RUTF daily for a period of 12 months The food supplements will be delivered to the participants home at weekly intervals
All children will undergo medical and anthropometric examinations at 4-monthly intervals and disease symptoms monitoring every week Dietary intake assessments will be conducted at 12 and 15 months of age A random sample of 36 children will undergo breast milk intake assessments before the start of food supplementation and during food supplementation A blood sample will be collected at the beginning and end of the study to measure blood haemoglobin and serum ferritin concentrations and test human immunodeficiency virus HIV at 6 and 18 months
The impact of the dietary interventions will be primarily assessed by comparing weight gain in the three intervention groups Secondary outcomes include length gain incidence of moderate underweight stunting and wasting cognitive and motor development at the end of trial and changes in blood haemoglobin and serum ferritin concentration The study will also produce descriptive data on morbidity and intake of breast milk and other 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