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

This study is not yet open for participant recruitment.
Verified July 2012 by Association for the Study and Prevention of HIV/AIDS
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:

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

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
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:

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
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013