Clinical Trial: Effectiveness and Cost-Effectiveness of Four Formulations of Food Supplements for the Prevention of Wasting and Stunting in Burkina Faso

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Food Aid Quality Review Phase II Effectiveness Study: Preventing MAM and Stunting in Burkina Faso

Brief Summary:

This research will serve as a follow-up on the review of Title II commodities performed by the Food Aid Quality Review at Tufts University in October 2011. The study in Burkina Faso will test the relative effectiveness and cost effectiveness of four supplementary foods in the prevention of MAM and stunting in normal programmatic settings.

The aims of this study are to:

  1. To compare the effectiveness of four alternative supplementary food commodities in preventing stunting and wasting, and promoting linear growth in children 6 - 23 months in the context of a preventive supplementary feeding program in Burkina Faso.
  2. To estimate the relative cost of implementing the supplementary feeding program using each commodity
  3. To estimate the relative cost/effectiveness of implementing the program using each commodity.

Detailed Summary:

Phase II of FAQR in Burkina Faso will assess the recommended improvements in the four arms of the study: CSB14 prepared with FVO, RUSF1, CSB+, and SC+.

The study will be a cluster-randomized, effectiveness trial. The study will use a mixed method technique of quantitative and qualitative data collection. The design of the study is quasi-experimental: food distribution sites (FDPs) (and the communities they serve) will be grouped into four clusters that are geographically contiguous with each other and sufficiently distant from each other so that the Beneficiaries are unlikely to have contact with each other. The four groups of food distribution points will be randomly assigned to one of four arms, defined by the specific food to be provided:

  1. Corn Soy Blend 14 (CSB14) (with whey protein concentrate and enhanced micronutrient profile), prepared with fortified vegetable oil (FVO); 75g CSB14/day, 22.5g FVO/day
  2. Ready-to use supplementary food 1 (RUSF1); 100g RUSF/day
  3. Super Cereal Plus (SC+)( has an enhanced nutrient profile, non-fat dry milk, and oil already embedded into the CSB); 122g SC+/day
  4. Corn Soy Blend Plus (CSB+) prepared with FVO; 75g CSB+/day, 22.5g FVO/day The CSB+ arm will act as a control

The intervention is implemented using the food distribution points providing supplementary food (CSB14, CSB+, RUSF, SC+) to children once they reach six months of age, and children from 6 to 23 months. This study will enroll all children as they turn six months of age and follow them through their 23rd month of age. Variables to be tracked include: age, sex, arm of study/commodity received ,Mid-Upper Arm Circumference (MUAC), height for age
Sponsor: Tufts University

Current Primary Outcome: Incidence of MAM and Stunting [ Time Frame: Monthly for 18 months ]

Primary outcomes to be measured are incidence of MAM and incidence of stunting during the 18 months of preventive supplementation (age 6 months to 23 months).

Stunting will be defined as less than -2 SD of Height-for-Age Z-score and MAM will be defined as less than -2 SD Weight-for-Height (length) Z-score



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Tufts University

Dates:
Date Received: September 23, 2013
Date Started: March 2014
Date Completion: August 2017
Last Updated: April 24, 2017
Last Verified: April 2017