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

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

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.

Study Overview

• Status: Unknown
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Beverage fortified with 21 vitamins and minerals; Dietary supplement: Lactose-free milk

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Victor Alfonso; Phone Number: +502 42196935; Email: valfonso@apevihs.org

Study Locations

• Guatemala
  • Retalhuleu, Guatemala
    • APEVIHS
    • Contact: Victor Alfonso; Phone Number: +502 42196935; Email: valfonso@apevihs.org
    • Principal Investigator: Victor Alfonso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fortified beverage; 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.	Dietary supplement: Beverage fortified with 21 vitamins and minerals; The serving contains 4 grs. of protein, 12 grs. of carbohydrate, 1 gr of fat 9 mg of zinc, 12.5 mg iron, 160 µg of folic acid, 90 µg of iodine, 250 mg of vitamin A, 40 mg of vitamin C, 0.5 mg of vitamin B6, 0.9 µg of vitamin B12, 6 mg of niacin, 0.5 mg of vitamin B2, 0.5 mg of vitamin B1, 0.3 mg of copper, 5 mg of vitamin D3, 5 mg of vitamin E, 200 mg ofcalcium, 150 mg of phosphorous, 40 mg of magnesium, 17 µg of selenium, 0.17 µg of manganese, 1.8 mg of pantothenic acid and 8 µg of biotin.; Other Names: Chispuditos®
Active Comparator: Group receiving 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.	Dietary supplement: Lactose-free milk; Serving contains 4 grs. of protein, 12 grs of carbohydrate and 1 gr of fat; Other Names: High nutritive value vegetable mix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Nutritional status	weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance	Months 0, 3, 6, 9, 12 and 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iron Status	Hemoglobin level and serum ferritin level	Months 0 and 16
Zinc status	serum zinc level	Months 0 and 16

Collaborators and Investigators

• Sponsor: Association for the Study and Prevention of HIV/AIDS
• Investigators: Study Chair: Gregory Reinhart, Mathile Institute

Publications and helpful links

General Publications

• Brown KH, Peerson JM, Rivera J, Allen LH. Effect of supplemental zinc on the growth and serum zinc concentrations of prepubertal children: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2002 Jun;75(6):1062-71. doi: 10.1093/ajcn/75.6.1062.
• Ministry of Social Health and Public Assistance et al. Micronutrient National Survey. Guatemala MSPAS 56pp. 2011
• Ministry of Public Health and Social Assistance. Maternal Infant Health Survey. Guatemala, MSPAS, 634 pp. 2010

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 13, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Estimate): July 18, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: APE-001