Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131417
Status:
UNKNOWN
Last Update Posted:
2005-10-05
First Post:
2005-08-17
Brief Title:
Ready to Use Therapeutic Food in the Rehabilitation of Severely Malnourished Children
Sponsor:
Makerere University
Organization:
Makerere University
Study Overview
Official Title:
Comparison of the Efficacy of a Ready-to-Use Therapeutic Food With a Milk-Based Diet in the Rehabilitation of Severely Malnourished Ugandan Children
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Severe malnutrition is a major cause of child morbidity and mortality in developing countries especially sub-Saharan Africa The hospital mortality rate due to severe malnutrition in developing countries ranges from 20-30 For the rehabilitation of severely malnourished children the World Health Organization WHO recommends a liquid milk-based diet Formula 100 F100 which contains 100 kilocalories per 100 milliliters In Uganda the rehabilitation of severely malnourished children is based on High Energy Milk HEM which is reconstituted cows milk with a nutritional composition similar to F100 Recently a semi-solid ready-to-use therapeutic food RUTF with similar composition as F100 or HEM has been designed This preparation can be eaten without adding water hence reducing the risk of bacterial contamination The preparation can be used at home with minimal supervision Hitherto the efficacy of RUTF in the rehabilitation of severely malnourished children in Uganda has not been studied The purpose of this study is to determine whether giving daily RUTF in the rehabilitation of severely malnourished children will result in a higher weight gain than giving HEM
Detailed Description:
Severe malnutrition is a major cause of child morbidity and mortality in developing countries especially sub-Saharan Africa The hospital case fatality rate of severely malnourished children in developing countries ranges from 20 to 30 In Uganda the prevalence of malnutrition remains high among children below 5 years 39 are stunted 4 are wasted and 23 are under weight For the rehabilitation of severely malnourished children the World Health Organization recommends a liquid milk-based diet formula 100 F100 which contains 100 kilocalories per 100 milliliters F100 is prepared by mixing dried skimmed milk oil sugar and mineral vitamin mix It provides 100 kilocalories of energy and contains 29 grams of protein per 100 milliliters In Uganda the rehabilitation of severely malnourished children is based on High Energy Milk HEM which is reconstituted cows milk with nutritional composition similar to F100
Recently a semi-solid ready- to- use therapeutic food RUTF whose nutrition composition is similar to F100 or HEM has been designed It is prepared by mixing full cream powder icing sugar ground nut paste vegetable oil and mineral vitamin mix RUTF contains 545 kilocalories per 100 grams of which 10 are protein calories and 59 lipid calories This preparation can be eaten without adding water hence reducing the risk of bacterial contamination and it can be used at home with minimum supervision RUTF has energy density of more than 5 times that of milk-based feeds Hitherto the efficacy of RUTF in the rehabilitation of severely malnourished children in Uganda has not been studied The purpose of this study is to determine whether giving daily RUTF in the rehabilitation of severely malnourished children results in a higher weight gain than giving HEM
Hypothesis Giving 5 meals of RUTF daily in the rehabilitation of severely malnourished children will result in a higher mean weight gain 10gkgday than giving 5 meals of HEM daily
The researchers calculated the minimum sample size of 64 patients in each group for 90 power and 95 confidence In the calculation the researchers assumed that the mean weight gain in the control HEM group would be 101 gkgday with standard deviation of 44g according to results of a study by Diop in Senegal and assumed that the mean weight gain in the RUTF group would be 1263gkgday 2505 effect size
Recently a semi-solid ready- to- use therapeutic food RUTF whose nutrition composition is similar to F100 or HEM has been designed It is prepared by mixing full cream powder icing sugar ground nut paste vegetable oil and mineral vitamin mix RUTF contains 545 kilocalories per 100 grams of which 10 are protein calories and 59 lipid calories This preparation can be eaten without adding water hence reducing the risk of bacterial contamination and it can be used at home with minimum supervision RUTF has energy density of more than 5 times that of milk-based feeds Hitherto the efficacy of RUTF in the rehabilitation of severely malnourished children in Uganda has not been studied The purpose of this study is to determine whether giving daily RUTF in the rehabilitation of severely malnourished children results in a higher weight gain than giving HEM
Hypothesis Giving 5 meals of RUTF daily in the rehabilitation of severely malnourished children will result in a higher mean weight gain 10gkgday than giving 5 meals of HEM daily
The researchers calculated the minimum sample size of 64 patients in each group for 90 power and 95 confidence In the calculation the researchers assumed that the mean weight gain in the control HEM group would be 101 gkgday with standard deviation of 44g according to results of a study by Diop in Senegal and assumed that the mean weight gain in the RUTF group would be 1263gkgday 2505 effect size
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