Skip to content

Efficacy of 3 Nutritional Supplements to Improve Diverse Outcomes in Children Under 2 Years of Age and Pregnant Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00531674
Enrollment
Unknown
Registered
2007-09-19
Start date
2005-09-30
Completion date
2007-10-31
Last updated
2014-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Efficacy of public health intervention (nutrition)

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.

Interventions

DIETARY_SUPPLEMENTfortified milk-based beverage

Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.

DIETARY_SUPPLEMENTSprinkles

Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.

DIETARY_SUPPLEMENTtablets

Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.

DIETARY_SUPPLEMENTFortified milk-based pap

Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for children.

DIETARY_SUPPLEMENTSyrup

Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.

Sponsors

Secretary of Social Development
CollaboratorUNKNOWN
Inter-American Development Bank
CollaboratorOTHER
Mexican National Institute of Public Health
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Child linear growth and weight gain24 mo of ageChild height and weight at 24 mo of age and increment from baseline to 24 mo of age
Child hemoglobin concentration and anemia prevalence10 mo of supplementation, at 24 mo of age, 6 mo after completion of supplementation (30 mo of age)
Pregnancy weight gain and weight retention37 wks pregnancy, 1 and 3 mo postpartum
Hemoglobin concentration and anemia prevalence37 wks pregnancy and 1 mo postpartum

Secondary

MeasureTime frame
Physical activity in childrenafter 4 and 12 mo of supplementation
Language adquisition and motor milestone development in childrenThroughout follow-up
Acceptability and use of the supplements (women and children)Children: after 2, 6 and 12 mo consumption; Women: following completion of trial and in pregnant women who did not participate in main study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026