Clinical Trial: Efficacy of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Efficacy of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia

Brief Summary: The purpose of this trial is to evaluate the efficacy of the LNS on children aged 6-17 months in preventing growth faltering and improving micronutrient status. The impact of product will be compared to Corn Soy Blend ++ (CSB++), Sprinkles, and to a control group consuming an unsupplemented diet, which is usually borbor at an early age, and thereafter, family foods.

Detailed Summary:

BACKGROUND:

In Cambodia, progress in combatting malnutrition has stalled. In 2010, 40% of all children under five (and 49% of 4-5 year-olds) were stunted, 11% were wasted, and 28% were underweight, indicating, respectively, chronic and acute malnutrition, and a combination of the two. Stunting is partially attributed to poor complementary feeding, which remains inadequate for achieving growth outcomes and micronutrient status.

Malnutrition can be prevented with supplementary foods. These foods usually contain a source of protein and lipids such as powered milk, soy or peanuts, and multiple micronutrients. They can be prepared as a fortified blended product, such as Corn-Soy Blend++ (CSB++), that is mixed with water to make a porridge, or ready-to-use supplementary foods (RUSFs). The latter are usually lipid-based nutrient supplements (LNSs) which are often pastes such as the peanut-based Plumpy'Nut™. These energy-dense supplementary foods contain both macro and micronutrients and are used to prevent and treat moderate acute malnutrition by promoting improved linear growth, weight gain and micronutrient status among children. Until recently, treatment of moderate acute malnutrition has relied on fortified blended products. The new RUSFs are also proving effective, as they are higher energy and have a longer shelf life, and since they require no preparation, are convenient. Another common nutrition intervention is multiple micronutrient supplements such as Sprinkles. These are individually-packed powders that can be added to food. However, micronutrients are more likely to achieve growth outcomes when they are combined with energy, for example, in lipid-based nutrient supplements and there is no evidence that micronutrient powders alone contribute to growth.

Until June
Sponsor: Institut de Recherche pour le Developpement, Cambodia

Current Primary Outcome: Nutritional status [ Time Frame: 6 months ]

Original Primary Outcome: Nutritional status [ Time Frame: 9 months ]

Current Secondary Outcome:

• Body composition [ Time Frame: 6 months ]
  Triceps, biceps and/or subscapular skinfolds
• Iron status [ Time Frame: 6 months ]
  Analysis of haemoglobin (g/l), ferritin (µg/l), tranferrin receptor (mg/l), C reactive protein (mg/l), and alpha-1-acid glycoprotein (mg/l)

Original Secondary Outcome:

• Body composition [ Time Frame: 9 months ]
  Triceps, biceps and/or subscapular skinfolds
• Iron status [ Time Frame: 9 months ]
  Analysis of haemoglobin (g/l), ferritin (µg/l), tranferrin receptor (mg/l), C reactive protein (mg/l), and alpha-1-acid glycoprotein (mg/l)

Information By: Institut de Recherche pour le Developpement, Cambodia

Dates:
Date Received: October 2, 2014
Date Started: February 2016
Date Completion: October 2016
Last Updated: September 13, 2016
Last Verified: September 2016