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Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI I)

NCT01312987 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-08-02

No results posted yet for this study

Summary

The purpose of this research study is to assess what impact an integrated educational and feeding intervention delivered to infants and children has on growth (weight and height), development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and micronutrient status - folate, iron, zinc, vitamin A, vitamin D), and morbidity (respiratory and diarrheal) outcomes. A randomized community trial was used to implement a nutrition intervention program consisting of monthly education sessions, a lipid-based nutrition supplement, and food vouchers for local staples.

Conditions

  • Malnutrition
  • Undernutrition

Interventions

DIETARY_SUPPLEMENT

Lipid-based nutritional supplement

After gradual introduction of the lipid-based nutritional supplement, daily dose per child is as follows: 3 teaspoons 3 x day for children younger than 12 months 4.5 teaspoons 3 x day for children older than 12 months

Sponsors & Collaborators

  • The Mathile Institute for the Advancement of Human Nutrition

    collaborator OTHER

  • Shoulder to Shoulder

    lead OTHER

Principal Investigators

  • Jeff Heck, MD · Shoulder to Shoulder

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-04-30
Completion
2010-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01312987 on ClinicalTrials.gov