Overview

This trial is active, not recruiting.

Conditions malnutrition, undernutrition
Treatment chispuditos
Sponsor Shoulder to Shoulder
Collaborator The Mathile Institute for the Advancement of Human Nutrition
Start date May 2010
End date December 2011
Trial size 639 participants
Trial identifier NCT01303016, MANI II, Shoulder to Shoulder

Summary

The purpose of this research study is to better understand how to prevent malnutrition in children under age 5 years in Intibuca, Honduras. A randomized community trial design was used to implement a nutrition program, including a complementary nutrition supplement, educational sessions, and growth and health monitoring integrated into the basic primary care package, to participants living in communities in the intervention group. Participants living in the control group communities will receive the nutrition supplement for one year following the study.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Receives a month's supply of the nutrition supplement, Chispuditos, in addition to a voucher for 1lb of powdered milk each month and a voucher for 1lb of sugar every other month.
chispuditos
Daily dose per child is 1 heaping Tablespoon of Chispuditos (using the appropriate measuring spoon provided to each participant), 1 teaspoon of sugar if desired (using appropriate measuring spoon provided to each participant), mixed with 8 ounces of water or milk. The mixture is stirred over a heat source (fire or stove) until the mixture boils for 8 minutes.
(No Intervention)
Receives a voucher for 1lb of powdered milk each month and a voucher for 1lb of sugar every other month. Participants in the control group will receive the nutrition supplement, Chispuditos, for one year after the study is complete.

Primary Outcomes

Measure
Height and weight
time frame: Every other month for 12 months
Hemoglobin
time frame: Baseline, month 6, and month 12
Retinol binding protein, transferrin receptor, and C-Reactive Protein
time frame: Baseline, month 6, and month 12

Secondary Outcomes

Measure
Food insecurity
time frame: Baseline, month 6, and month 12
Health outcomes
time frame: Baseline, month 6, and month 12
Acceptability/Sustainability of nutrition supplement
time frame: Baseline, month 3, and month 8

Eligibility Criteria

Male or female participants from 6 months up to 5 years old.

Inclusion Criteria: - Children between the ages of 6 months and under 5 years at the time enrollment who reside in Concepcion. Exclusion Criteria: - Children with congenital anomalies, mental retardation, severe physical handicap, undernutrition caused by medical conditions that contribute to undernutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, and chronic diseases such as tuberculosis, etc. - Plans to move or change place of residence outside the intervention region in the next 2 months. - Children whose weight for age z score falls below - 3. - Children whose weight for age z score is above 3.

Additional Information

Official title Improving Nutrition and Health Outcomes in Intibuca, Honduras
Principal investigator Jeff Heck, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Shoulder to Shoulder.