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

November 6, 2014 updated by: Mexican National Institute of Public Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Nutrivida
Dietary supplement: Sprinkles
Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
Other Names:
  • Vita-mine for children
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: Sprinkles
Powder with multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.
Other Names:
  • Vita-mine 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 Names:
  • Nutrisano
Dietary supplement: Syrup
Multiple vitamins and minerals (1 RDA). Identifical dose and formulation as other supplements for women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
37 wks pregnancy, 1 and 3 mo postpartum
Hemoglobin concentration and anemia prevalence
Time Frame: 37 wks pregnancy and 1 mo postpartum
37 wks pregnancy and 1 mo postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
after 4 and 12 mo of supplementation
Language adquisition and motor milestone development in children
Time Frame: Throughout follow-up
Throughout follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mexican National Institute of Public Health

Collaborators

Inter-American Development Bank
Secretary of Social Development

Investigators

  • Principal Investigator: Lynnette M Neufeld, PhD, National Institute of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 18, 2007

First Submitted That Met QC Criteria

September 18, 2007

First Posted (Estimate)

September 19, 2007

Study Record Updates

Last Update Posted (Estimate)

November 7, 2014

Last Update Submitted That Met QC Criteria

November 6, 2014

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPH472

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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