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

NCT00531674 | Completed

• 1 other identifier: NIPH472
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Efficacy of public health intervention (nutrition)

Outcome Measures

Primary Outcomes (4)

• Child linear growth and weight gain

  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

  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

  37 wks pregnancy, 1 and 3 mo postpartum

• Hemoglobin concentration and anemia prevalence

  37 wks pregnancy and 1 mo postpartum

Secondary Outcomes (3)

• 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

• Physical activity in children

  after 4 and 12 mo of supplementation

• Language adquisition and motor milestone development in children

  Throughout follow-up

Study Arms (2)

1

EXPERIMENTAL

Nutritional supplementation for pregnant and lactating women

Dietary Supplement: fortified milk-based beverage; Dietary Supplement: Sprinkles; Dietary Supplement: tablets

2

EXPERIMENTAL

Nutritional supplementation for children

Dietary Supplement: Fortified milk-based pap; Dietary Supplement: Sprinkles; Dietary Supplement: Syrup

Interventions

fortified milk-based beverage DIETARY_SUPPLEMENT

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

Also known as: Nutrivida

1

Sprinkles DIETARY_SUPPLEMENT

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

Also known as: Vita-mine for pregnant and lactating women

1

tablets DIETARY_SUPPLEMENT

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

1

Fortified milk-based pap DIETARY_SUPPLEMENT

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

Also known as: Nutrisano

2

Syrup DIETARY_SUPPLEMENT

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

2

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pregnant women before 27 wks pregnancy (Arm 1)
• 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)

You may not qualify if:

• Severe anemia (Arm 1 and 2)
• Consuming other nutritional supplements and unwilling to descontinue use (Arm 1 and 2)

Sponsors & Collaborators

• Mexican National Institute of Public Health: lead
• Secretary of Social Development: collaborator
• Inter-American Development Bank: collaborator

Related Publications (1)

• Neufeld LM, Garcia-Guerra A, Quezada AD, Theodore F, Bonvecchio Arenas A, Islas CD, Garcia-Feregrino R, Hernandez A, Colchero A, Habicht JP. A Fortified Food Can Be Replaced by Micronutrient Supplements for Distribution in a Mexican Social Protection Program Based on Results of a Cluster-Randomized Trial and Costing Analysis. J Nutr. 2019 Dec 1;149(Suppl 1):2302S-2309S. doi: 10.1093/jn/nxz176.

  PMID: 31793645 DERIVED

Related Links

• Home page, National Institute of Public Health, Mexico

MeSH Terms

Interventions

Gravidity; Tablets

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Pregnancy; Reproduction; Reproductive History; Epidemiologic Factors; Public Health; Environment and Public Health; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Lynnette M Neufeld, PhD

  National Institute of public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: September 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: November 7, 2014

Record last verified: 2012-11