Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children From the Takalik Abaj
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Malnutrition
- Sponsor
- Association for the Study and Prevention of HIV/AIDS
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Change in Nutritional status
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to measure the impact of a fortified food on the nutritional and micronutrient status of malnourished children, compared with milk. The changes to be evaluated include the indicators weight for height, height for age, weight for age, mid-arm circumferance for age; and levels of hemoglobin, serum zinc, serum ferritin, serum folic acid, erythrocyte folic acid, serum vitamin B12, and urinary iodine.
Detailed Description
Chronic malnutrition evidenced by short height for age is a common nutritional problem in underdeveloped countries which is generally accompanied by iron deficiency anemia and zinc deficiency. It has many consequences on the adult including limited capacity to work and higher risk of obesity and chronic disease. The present study will offer a fortified food, culturally accepted and locally produced. The effectiveness of this fortified food compared to lactose-free milk, in a controlled dose and with no risk to the health of the study participants, will be determined. Both will be distributed for free to be consumed as an atole or in liquid form, respectively, at a community level in an environment controlled as much as possible. This will allow to determine adherence, acceptability, consumption and distribution within the family.
Investigators
Victor Alfonso Mayen
Nutritionist, Magister Science
Association for the Study and Prevention of HIV/AIDS
Eligibility Criteria
Inclusion Criteria
- •Some degree of malnutrition according to weight for height or height for age
- •Reside in one of the six communities chosen for the study
Exclusion Criteria
- •Down syndrome
- •Renal failure
Outcomes
Primary Outcomes
Change in Nutritional status
Time Frame: Months 0, 3, 6, 9, 12 and 15 months
weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance
Secondary Outcomes
- Iron Status(Months 0 and 16)
- Zinc status(Months 0 and 16)