fortified milk-based beverage
Dietary SupplementFortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
Other names: Nutrivida
NCT Number: NCT00531674
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.
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Notify Me6 month–12 month
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
Other names: Nutrivida
Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
Other names: Vita-mine for pregnant and lactating 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.
Other names: Nutrisano
Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
Time frame: 24 mo of age
Child height and weight at 24 mo of age and increment from baseline to 24 mo of age
Time frame: 10 mo of supplementation, at 24 mo of age, 6 mo after completion of supplementation (30 mo of age)
Time frame: 37 wks pregnancy, 1 and 3 mo postpartum
Time frame: 37 wks pregnancy and 1 mo postpartum
Time frame: Children: after 2, 6 and 12 mo consumption; Women: following completion of trial and in pregnant women who did not participate in main study
Time frame: after 4 and 12 mo of supplementation
Time frame: Throughout follow-up
Mexican National Institute of Public Health
Other Gov
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