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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01643187
• Other study ID #: APE-001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: July 13, 2012
• Last updated: July 16, 2012
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: Association for the Study and Prevention of HIV/AIDS
• Contact: Victor Alfonso
• Phone: +502 42196935
• Email: valfonso[@]apevihs.org
• Is FDA regulated: No
• Health authority: Guatemala: Ministry of Public Health and Social Assistance
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 72 Months

Eligibility

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

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

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.
• Lactose-free milk
Serving contains 4 grs. of protein, 12 grs of carbohydrate and 1 gr of fat

Locations

Country	Name	City	State
Guatemala	APEVIHS	Retalhuleu

Sponsors (1)

Lead Sponsor	Collaborator
Association for the Study and Prevention of HIV/AIDS

Country where clinical trial is conducted

Guatemala, 

References & Publications (3)

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. — View Citation

Ministry of Public Health and Social Assistance. Maternal Infant Health Survey. Guatemala, MSPAS, 634 pp. 2010

Ministry of Social Health and Public Assistance et al. Micronutrient National Survey. Guatemala MSPAS 56pp. 2011

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Iron Status	Hemoglobin level and serum ferritin level	Months 0 and 16	No
Secondary	Zinc status	serum zinc level	Months 0 and 16	No