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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01303016
Other study ID # MANI II, Shoulder to Shoulder
Secondary ID
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


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
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