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OpenTrials
Completed

NCT Number: NCT00531674

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

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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Key information

Conditions

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

fortified milk-based beverage

Dietary Supplement

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

Other names: Nutrivida

SPRINKLES

Dietary Supplement

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

tablets

Dietary Supplement

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

Fortified milk-based pap

Dietary Supplement

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

Other names: Nutrisano

Syrup

Dietary Supplement

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

Primary outcomes

  1. Child linear growth and weight gain

    Time frame: 24 mo of age

    Child height and weight at 24 mo of age and increment from baseline to 24 mo of age

  2. Child hemoglobin concentration and anemia prevalence

    Time frame: 10 mo of supplementation, at 24 mo of age, 6 mo after completion of supplementation (30 mo of age)

  3. Pregnancy weight gain and weight retention

    Time frame: 37 wks pregnancy, 1 and 3 mo postpartum

  4. Hemoglobin concentration and anemia prevalence

    Time frame: 37 wks pregnancy and 1 mo postpartum

Secondary outcomes

  1. Acceptability and use of the supplements (women and children)

    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

  2. Physical activity in children

    Time frame: after 4 and 12 mo of supplementation

  3. Language adquisition and motor milestone development in children

    Time frame: Throughout follow-up

Sponsors and collaborators

Lead sponsor

Mexican National Institute of Public Health

Other Gov

Collaborators

  • Inter-American Development Bank
  • Secretary of Social Development

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2007
Registry last updated
Nov 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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