Clinical trial NCT00531674: Efficacy of 3 Nutritional Supplements to Improve Diverse Outcomes in Children Under 2 Years of Age and Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Efficacy of public health intervention (nutrition)
Lead sponsor: Mexican National Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: Secretary of Social Development
name: Inter-American Development Bank
First posted: 2007-09-19
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Pregnant women before 27 wks pregnancy (Arm 1)
* 18 yrs of age and older (Arm 1)
* Children 6 to 12 mo of age (Arm 2)
* Beneficiaries of the Oportunidades programa (Arm 1 and 2)

Exclusion Criteria:

* Severe anemia (Arm 1 and 2)
* Consuming other nutritional supplements and unwilling to descontinue use (Arm 1 and 2)

Primary outcomes:
measure: Child linear growth and weight gain
timeFrame: 24 mo of age
measure: Child hemoglobin concentration and anemia prevalence
timeFrame: 10 mo of supplementation, at 24 mo of age, 6 mo after completion of supplementation (30 mo of age)
measure: Pregnancy weight gain and weight retention
timeFrame: 37 wks pregnancy, 1 and 3 mo postpartum
measure: Hemoglobin concentration and anemia prevalence
timeFrame: 37 wks pregnancy and 1 mo postpartum
Secondary outcomes:
measure: Acceptability and use of the supplements (women and children)
timeFrame: Children: after 2, 6 and 12 mo consumption; Women: following completion of trial and in pregnant women who did not participate in main study
measure: Physical activity in children
timeFrame: after 4 and 12 mo of supplementation
measure: Language adquisition and motor milestone development in children
timeFrame: Throughout follow-up
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of public Health
name: Lynnette M Neufeld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neufeld LM, Garcia-Guerra A, Quezada AD, Theodore F, Bonvecchio Arenas A, Islas CD, Garcia-Feregrino R, Hernandez A, Colchero A, Habicht JP. A Fortified Food Can Be Replaced by Micronutrient Supplements for Distribution in a Mexican Social Protection Program Based on Results of a Cluster-Randomized Trial and Costing Analysis. J Nutr. 2019 Dec 1;149(Suppl 1):2302S-2309S. doi: 10.1093/jn/nxz176.