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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2012 by Association for the Study and Prevention of HIV/AIDS.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

Victor Alfonso Mayen, Association for the Study and Prevention of HIV/AIDS

ClinicalTrials.gov Identifier:

NCT01643187

First received: July 13, 2012

Last updated: July 16, 2012

Last verified: July 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Malnutrition	Dietary Supplement: Beverage fortified with 21 vitamins and minerals Dietary Supplement: Lactose-free milk	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children From the Takalik Abaj

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

Further study details as provided by Association for the Study and Prevention of HIV/AIDS:

Primary Outcome Measures:

Change in Nutritional status [ Time Frame: Months 0, 3, 6, 9, 12 and 15 months ] [ Designated as safety issue: No ]
weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance

Secondary Outcome Measures:

Iron Status [ Time Frame: Months 0 and 16 ] [ Designated as safety issue: No ]
Hemoglobin level and serum ferritin level
Zinc status [ Time Frame: Months 0 and 16 ] [ Designated as safety issue: No ]
serum zinc level


Estimated Enrollment:	1000
Study Start Date:	July 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: High nutritive value vegetable mix

Arms

Assigned Interventions

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 Name: 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 Name: High nutritive value vegetable mix

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.

Eligibility


Ages Eligible for Study:	6 Months to 72 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643187

Contacts


Contact: Victor Alfonso	+502 42196935	valfonso@apevihs.org

Locations


Guatemala
APEVIHS	Not yet recruiting
Retalhuleu, Guatemala
Contact: Victor Alfonso +502 42196935 valfonso@apevihs.org
Principal Investigator: Victor Alfonso

Sponsors and Collaborators

Association for the Study and Prevention of HIV/AIDS

Investigators


Study Chair:	Gregory Reinhart	Mathile Institute

More Information

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.


Responsible Party:	Victor Alfonso Mayen, Nutritionist, Magister Science, Association for the Study and Prevention of HIV/AIDS
ClinicalTrials.gov Identifier:	NCT01643187 History of Changes
Other Study ID Numbers:	APE-001
Study First Received:	July 13, 2012
Last Updated:	July 16, 2012
Health Authority:	Guatemala: Ministry of Public Health and Social Assistance

Additional relevant MeSH terms:


Malnutrition Nutrition Disorders Micronutrients Trace Elements	Vitamins Growth Substances Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 25, 2015

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