Effectiveness and Cost-Effectiveness of Four Formulations of Food Supplements for the Prevention of Wasting and Stunting in Burkina Faso (FAQR-Burkina)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02071563|
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : October 24, 2017
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:
- 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.
- To estimate the relative cost of implementing the supplementary feeding program using each commodity
- To estimate the relative cost/effectiveness of implementing the program using each commodity.
|Condition or disease||Intervention/treatment||Phase|
|Child Malnutrition||Dietary Supplement: CSB14 Dietary Supplement: RUSF1 Dietary Supplement: SC+||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6039 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Food Aid Quality Review Phase II Effectiveness Study: Preventing MAM and Stunting in Burkina Faso|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||June 2017|
Active Comparator: CSB14
Isocaloric amount and cost-effectiveness of CSB14 (with whey protein concentrate and enhanced micronutrient profile), prepared with fortified vegetable oil (FVO).
|Dietary Supplement: CSB14|
Active Comparator: RUSF1
Isocaloric amount and cost-effectiveness of Ready-to Use Supplementary Food 1(RUSF1), USAID's Lipid-Based Nutrient Supplement (LNS) product
|Dietary Supplement: RUSF1|
Active Comparator: SC+
Isocaloric amount and cost-effectiveness of Supercereal Plus (SC+), the FBF used by WFP, which has an enhanced nutrient profile, dairy ingredient (non-fat dry milk), and oil already embedded into the flour
|Dietary Supplement: SC+|
No Intervention: CSB+
Isocaloric amount and cost-effectiveness of Supercereal/CSB+ prepared with FVO.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071563
|Kaya, Sanmatenga, Burkina Faso|
|Principal Investigator:||Beatrice L Rogers, PhD||Tufts University|