Improving Nutrition and Health Outcomes in Intibuca, Honduras

Malnutrition Clinical Trial

— MANI II  

Official title:

Improving Nutrition and Health Outcomes in Intibuca, Honduras

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01303016
• Other study ID #: MANI II, Shoulder to Shoulder
• Status: Active, not recruiting
• Phase: N/A
• First received: February 23, 2011
• Last updated: March 5, 2011
• Start date: May 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2011
• Source: Shoulder to Shoulder
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 639
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shoulder to Shoulder	The Mathile Institute for the Advancement of Human Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height and weight	Participating children are measured and weighed by trained staff every other month during the 12 month intervention.	Every other month for 12 months	No
Primary	Hemoglobin	Hemoglobin values are measured using a One STAT Site M meter instrument and recorded to the nearest g/dL at baseline, month 6, and month 12 of the intervention.	Baseline, month 6, and month 12	No
Primary	Retinol binding protein, transferrin receptor, and C-Reactive Protein	Retinol binding protein, transferrin, and C-Reactive Protein are measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention.	Baseline, month 6, and month 12	No
Secondary	Food insecurity	Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.	Baseline, month 6, and month 12	No
Secondary	Health outcomes	Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.	Baseline, month 6, and month 12	No
Secondary	Acceptability/Sustainability of nutrition supplement	Assessment teams administer a scored questionnaire at baseline, month 3, and month 8 of the intervention	Baseline, month 3, and month 8	No