Efficacy of 3 Nutritional Supplements to Improve Diverse Outcomes in Children Under 2 Years of Age and Pregnant Women
Condition: Healthy
Study type: Interventional

Summary: 
      The Mexican poverty alleviation program, Oportunidades provides a fortified food supplement
      to all beneficiary children under 2 years of age, and all pregnant and lactating women.
      Consumption of the supplements is well below recommended levels and the impact of the program
      on child growth and anemia is less than anticipated. This is likely due to a high degree of
      dilution by sharing of the supplements with other family members. We have also found evidence
      of a very high prevalence of overweight and obesity among beneficiaries of Oportunidades in
      both women and children.

      Given the micronutrient content of the fortified food, it is likely that the impact of the
      program on child growth and the micronutrient status of women and children would improve
      considerable if the supplements were consumed daily in the recommended dose. This may be
      difficult, given the wide-spread sharing within households - something that has been
      identified by many beneficiary families as a desirable behavior. At the same time, we do not
      know whether daily consumption of the food, which contains approximately 20% of daily energy
      requirements, may contribute to undesirable weight gain in this population.

      In this context, we have designed a cluster randomized controlled efficacy trail to compare
      the nutritional impact, acceptability and use of three nutritional supplements. Supplements
      were randomly assigned at the community level (n=54), and pregnant women (n=750) and children
      6 to 12 mo of age (n=900) invited to participate. The principal objective of the study is to
      compare the impact of Sprinkles and Nutrisano/Nutrivida using syrup/pills as a positive
      control group, on child growth, weight gain and retention in pregnant women, and
      micronutrient status of women and children. We hypothesize that weight gain will be greater
      in the food group compared to the other two supplementation groups, but impacts on
      micronutrient status and length growth in children will be similar.
    


Intervention name(s): fortified milk-based beverage; Sprinkles; tablets; Fortified milk-based pap; Sprinkles; Syrup
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.; Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.; Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.; Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for children.; Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.; Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
Other intervention name(s): Nutrivida; Vita-mine for pregnant and lactating women; Nutrisano; Vita-mine for children
Intervention MeSH terms: Tocopherols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Efficacy of public health intervention (nutrition)