Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children

Malnutrition Clinical Trial

Official title: Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children From the Takalik Abaj

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

• Malnutrition

• NCT number: NCT01643187
• Study type: Interventional
• Source: Association for the Study and Prevention of HIV/AIDS
• Contact: Victor Alfonso
• Phone: +502 42196935
• Email: valfonso@apevihs.org
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2012
• Completion date: December 2013