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

Phase 2

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Beverage fortified with 21 vitamins and minerals; Dietary Supplement: Lactose-free milk

• Registration Number: NCT01643187
• Lead Sponsor: Association for the Study and Prevention of HIV/AIDS

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.

Study Timeline

• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-16
• Last Update Submitted: 2012-07-16
• Study First Posted: 2012-07-18
• Last Update Posted: 2012-07-18
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

• Leukemia
• Diabetes
• Handicap
• Down syndrome
• Renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fortified beverage	Beverage fortified with 21 vitamins and minerals	A group of children with some degree of malnourishment considered by a Z-score \< -1 for weight for height, height for age or weight for age.
Group receiving lactose-free milk	Lactose-free milk	A group of children with some degree of malnourishment considered by a Z-score \< -1 for weight for height, height for age or weight for age.

Primary Outcome Measures

Name	Time	Method
Change in Nutritional status	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 Outcome Measures

Name	Time	Method
Iron Status	Months 0 and 16	Hemoglobin level and serum ferritin level
Zinc status	Months 0 and 16	serum zinc level

Trial Locations

Locations (1)

APEVIHS; 🇬🇹 Retalhuleu, Guatemala