Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention
Healthy
Dietary Supplement: fortified milk-based beverage
Dietary Supplement: Sprinkles
Dietary Supplement: tablets
Dietary Supplement: Fortified milk-based pap
Dietary Supplement: Syrup

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)

Resource links provided by NLM:


Further study details as provided by Mexican National Institute of Public Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Study Start Date: September 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nutritional supplementation for pregnant and lactating women
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.
Experimental: 2
Nutritional supplementation for children
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.

  Eligibility

Ages Eligible for Study:   6 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531674

Sponsors and Collaborators
Mexican National Institute of Public Health
Secretary of Social Development
Interamerican Development Bank
Investigators
Principal Investigator: Lynnette M Neufeld, PhD National Institute of public Health
  More Information

Additional Information:
No publications provided

Responsible Party: Armando Garcia Guerra, National Institute of Public Health
ClinicalTrials.gov Identifier: NCT00531674     History of Changes
Other Study ID Numbers: NIPH472
Study First Received: September 18, 2007
Last Updated: November 6, 2014
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Mexican National Institute of Public Health:
Efficacy of public health intervention (nutrition)

ClinicalTrials.gov processed this record on November 25, 2014