Malnutrition Clinical Trial
— MANI IIOfficial title:
Improving Nutrition and Health Outcomes in Intibuca, Honduras
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shoulder to Shoulder | The Mathile Institute for the Advancement of Human Nutrition |
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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