The ready-to-use supplementary food's impact on indicators of malnutrition in mild and moderately wasted children: a randomized controlled trial

Primary Investigators

  • Fatemeh Azimi
  • Mohamad Javad Hosseinzadeh

Study Period

February 2017 - February 2018

Study Description

This study is a randomized controlled clinical trial, and 106 children will be studied for eight weeks. Inclusion criteria are having age 24 to 59 months; mild and moderate malnutrition without edema (Anthropometric index of weight for height between the -1 and -3 z-score); filling a consent form. Exclusion criteria are being twins; food allergies and intolerance; severe anemia; liver-kidney disease; malabsorption syndrome; unwillingness to cooperate. After enrollment, children will be allocated into two groups (Intervention and Control groups) based on random number table. Intervention group will receive the formula and the control group on the other will not. At baseline and during examination sessions, caregivers will be trained about Childhood nutrition. Before initiating the intervention, we will ask caregivers to give 5 grams of sample to children in the intervention group in case of checking for food intolerance. In absence of food intolerance, we will measure and record their weight, height and weight for height anthropometric index. In addition, during examination sessions, we will ask questions about the frequency of symptoms such as diarrhea, anorexia and abdominal pain. Also, we will take two Food records from caregivers which will show food consumed by children. After intervention we will measure and record their weight, height and weight for height anthropometric index. The primary outcome will be recovery (Increment of children's weight for height anthropometric index to the top of -1 z-score). The Secondary outcomes will be average increment of weight gain, height gain, and incidence of fever and diarrhea among children.

Study Arms

  • Intervention: the RUSF, which contains whey protein, egg white, soy, palm, starch, honey, sugar, oil and natural flavorings will be given to children as daily snacks for 8 weeks. On average, each should consume 1-3 packs (100g) daily + nutrition education
  • Control: before and during intervention, in four half-hour sessions, caregivers will be trained about childhood nutrition by face to face method.

Primary Outcomes

  • Recovery: Increase children's weight for height anthropometric index z-score to the top of -1 in weight-for-height tables Children's World Health Organization, Weight will be measured with scale, and height will be measured with meter.

Study Interventions

  • Standard Lipid-Based Nutrient Supplements (LNS)
  • Other
  • Locally produced

Research Gaps

  • Effectiveness

    How well do different food compositions and interventions prevent or treat undernutrition, when implemented "on the ground"?

  • Innovation

    What novel food-based products and programming methods effectively prevent and treat undernutrition?

Study Population

106