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

Association for the Study and Prevention of HIV/AIDS

Status and phase: Unknown; Phase 2

Conditions: Malnutrition

Treatments: Dietary Supplement: Lactose-free milk; Dietary Supplement: Beverage fortified with 21 vitamins and minerals

Study type: Interventional

Funder types: Other

Identifiers

NCT01643187

APE-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 6 to 72 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Fortified beverage

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Beverage fortified with 21 vitamins and minerals

Group receiving lactose-free milk

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Lactose-free milk