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

This study has been completed.
Sponsor:
Collaborators:
Secretary of Social Development
Interamerican Development Bank
Information provided by:
Mexican National Institute of Public Health
ClinicalTrials.gov Identifier:
NCT00531674
First received: September 18, 2007
Last updated: November 6, 2014
Last verified: November 2012

September 18, 2007
November 6, 2014
September 2005
October 2007   (final data collection date for primary outcome measure)
  • Child linear growth and weight gain [ Time Frame: 24 mo of age ] [ Designated as safety issue: No ]
    Child height and weight at 24 mo of age and increment from baseline to 24 mo of age
  • 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) ] [ Designated as safety issue: No ]
  • Pregnancy weight gain and weight retention [ Time Frame: 37 wks pregnancy, 1 and 3 mo postpartum ] [ Designated as safety issue: No ]
  • Hemoglobin concentration and anemia prevalence [ Time Frame: 37 wks pregnancy and 1 mo postpartum ] [ Designated as safety issue: No ]
  • Child linear growth and weight gain [ Time Frame: 24 mo of age ]
  • 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) ]
  • Pregnancy weight gain and weight retention [ Time Frame: 37 wks pregnancy, 1 and 3 mo postpartum ]
  • Hemoglobin concentration and anemia prevalence [ Time Frame: 37 wks pregnancy and 1 mo postpartum ]
Complete list of historical versions of study NCT00531674 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Physical activity in children [ Time Frame: after 4 and 12 mo of supplementation ] [ Designated as safety issue: No ]
  • Language adquisition and motor milestone development in children [ Time Frame: Throughout follow-up ] [ Designated as safety issue: No ]
  • 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 ]
  • Physical activity in children [ Time Frame: after 4 and 12 mo of supplementation ]
  • Language adquisition and motor milestone development in children [ Time Frame: Throughout follow-up ]
Not Provided
Not Provided
 
Efficacy of 3 Nutritional Supplements to Improve Diverse Outcomes in Children Under 2 Years of Age and Pregnant Women
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Healthy
  • Dietary Supplement: fortified milk-based beverage
    Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
    Other Name: Nutrivida
  • Dietary Supplement: Sprinkles
    Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
    Other Name: Vita-mine for pregnant and lactating women
  • Dietary Supplement: tablets
    Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
  • Dietary Supplement: Fortified milk-based pap
    Fortified with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for children.
    Other Name: Nutrisano
  • Dietary Supplement: Sprinkles
    Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
    Other Name: Vita-mine for children
  • Dietary Supplement: Syrup
    Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
  • Experimental: 1
    Nutritional supplementation for pregnant and lactating women
    Interventions:
    • Dietary Supplement: fortified milk-based beverage
    • Dietary Supplement: Sprinkles
    • Dietary Supplement: tablets
  • Experimental: 2
    Nutritional supplementation for children
    Interventions:
    • Dietary Supplement: Fortified milk-based pap
    • Dietary Supplement: Sprinkles
    • Dietary Supplement: Syrup
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
October 2007
October 2007   (final data collection date for primary outcome measure)

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)
Both
6 Months to 12 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00531674
NIPH472
No
Armando Garcia Guerra, National Institute of Public Health
Mexican National Institute of Public Health
  • Secretary of Social Development
  • Interamerican Development Bank
Principal Investigator: Lynnette M Neufeld, PhD National Institute of public Health
Mexican National Institute of Public Health
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP