Each of these studies is developing or testing formulas including dairy ingredients for their efficacy in preventing or treating malnutrition or related illnesses.  If you are conducting research, we invite you to send a brief announcement for posting, along with contact information to allow readers to send questions, to info@dairyforglobalnutrition.org. 

Application: Treatment of Moderate Acute Malnutrition

Target Population: Children 6 months — 35 months

Ingredients: 1) Plumpy'Sup, 2) Local Food supplement (milled, cowpea flour, sugar, vegetable oil and a micronutrient powder), 3) Misola (millet-soy-peanut-based fortified complementary food), 4) SCSB (corn-soy-milk-based food blend)

Location of Study: Mali

Principal Investigator: Kenneth H. Brown, MD, Helen Keller International

From ClinicalTrial.Gov, #NCT01015950: The objectives of the study are to assess the impact of different dietary strategies for the management of children with MAM on: the children's continued participation in the nutritional rehabilitation program and their physical growth, recovery from MAM, and change in micronutrient status and body composition. The specific dietary regimens that will be compared are: 1) a ready-to-use, lipid-based supplementary food (Plumpy'Sup, Nutriset, Inc.), providing ~500 kcal/d for 12 weeks; 2) specially formulated CSB for malnourished children, providing ~ 500 kcal/d for 12 weeks; 3) Misola, a locally produced, micronutrient-fortified, cereal-legume blend, providing ~500 kcal/d for 12 weeks; or 4) packaged, home available foods (millet and cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("Mix Me") for 12 weeks, as is currently recommended by the national CMAM protocol when special foods are not available. Sponsors and Collaborators: Helen Keller International; University of Bamako; University of California, Davis; UNICEF; United Nations World Food Programme (WFP). Contact Person: Kenneth H. Brown, MD

  

Application: Treatment of Moderate Acute Malnutrition

Target Population:  Children 6-59 months

Ingredient: 1) WPC (80) containing RUSF 2) Peanut/soy RUSF

Location of Study: Malawi

Principal Investigator: Mark Manary, MD, Washington University School of Medicine

From ClinicalTrials.Gov, # NCT01790048: The purpose of this study is to test the effectiveness of two supplementary foods, whey RUSF and soy RUSF, in the treatment of moderate acute malnutrition (MAM) in 6-59 month old children in a 12-week home-based supplementary feeding program. Sponsors and collaborators: Washington School of Medicine. Contact person: Dr. Mark Manary (manary@kids.wustl.edu)

 

Application: Treatment of Severe Acute Malnutrition

Target Population: Children under 5

Ingredients: 1) Soy-based RUTF, 2) Standard RUTF

Location of Study: Bangladesh

Principal Investigator: Md Iqbal Hossain, MBBS, DCH, Phd, International Centre for Diarrhoeal Disease Research, Bangladesh

From ClinicalTrials.Gov, #NCT01634009: SAM defined by having weight-for-height (WH) less than - 3 Z score or bi-pedal nutritional edema is an important cause of death in children globally including Bangladesh. The death rate among children hospitalized for SAM is still high. Severe malnutrition in children can be successfully treated by using WHO guidelines with or without minor modification. Since the Community Based Therapeutic Care (CTC)/CMAM approach was developed, the use of RUTF for the treatment of children with SAM has gained ground, and huge amounts of RUTF are used particularly in African countries. RUTFs are an energy-dense lipid paste enriched with vitamins and minerals. The typical composition (ingredient % of weight) of RUTF is whole milk powder 30%; sugar 28%; vegetable oil 15.4%; peanut paste 25%; and mineral vitamin mix 1.6%. Although the CTC model promises treatment of SAM at a considerably lower cost than the previous inpatient model, the cost of RUTF is still considered a significant barrier to universal roll-out of SAM treatment and has made CTC implementation too expensive in many high-need countries. The single most expensive raw ingredient in RUTF is milk powder, contributing around 50% of raw ingredient cost or between 30-35% of the total cost of the final product. Isolated soy protein has a cost per kg protein that normally is below that of skim or whole milk powder, and can thus reduce the total cost of RUTF. In addition, isolated soy protein (ISP) is a high quality, complete protein that meets the daily protein requirements of growing children and adults. ISP is a highly digestible protein [FAO/WHO, 1991] with an amino acid profile that has been shown to achieve a Protein Digestibility-Corrected Amino Acid Score (PDCAAS) of 1.00, comparable to milk and eggs, and has been shown to maintain nitrogen balance when fed as the sole protein source at minimum recommended intake levels. To compare the efficacy (weight gain, rate of weight gain and change of lean body mass) of the standard RUTF and an RUTF made from ISP (Soy-RUTF) through a randomized double masked intervention trial 300 SAM children aged 6 to 59 months after completion of their stabilization phase from the Dhaka Hospital of icddr,b Bangladesh will be studied. They will randomly receive standard- or Soy-RUTF as take home and followed up (weekly until achieving -2 WHZ, and thereafter fortnightly until achieving -1 WHZ) at the nutrition follow up unit at the outpatient department of this Dhaka Hospital of icddr,b. Sponsors and Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh. Contact Person: Md Iqbal Hossain (ihossain@icddrb.org)

 

Application: Preventing of Wasting and Stunting in Children

Target Population: Children 6-23 months

Ingredient: 1) CSB14, 2) RUSF1 (USAID's LNS product), SC+, CSB+

Location of Study: Burkina Faso

Principal Investigator: Beatrice L. Rogers, PhD, Tufts University

From ClinicalTrials.Gov, # NCT02071563: 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 will test the relative effectiveness and cost effectiveness of four supplementary foods in the prevention of MAM and stunting in normal programmatic settings. Sponsors and Collaborators: Tufts University; United States Agency for International Development (USAID); ACDI/VOCA; Save the Children. Contact person: Beatrice L. Rogers, PhD (Beatrice.rogers@tufts.edu).