Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children
Primary Purpose
Malnutrition
Status
Unknown status
Phase
Phase 2
Locations
Guatemala
Study Type
Interventional
Intervention
Beverage fortified with 21 vitamins and minerals
Lactose-free milk
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition
Eligibility 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
Sites / Locations
- APEVIHS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fortified beverage
Group receiving lactose-free milk
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in Nutritional status
weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance
Secondary Outcome Measures
Iron Status
Hemoglobin level and serum ferritin level
Zinc status
serum zinc level
Full Information
NCT ID
NCT01643187
First Posted
July 13, 2012
Last Updated
July 16, 2012
Sponsor
Association for the Study and Prevention of HIV/AIDS
1. Study Identification
Unique Protocol Identification Number
NCT01643187
Brief Title
Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children
Official Title
Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children From the Takalik Abaj
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Association for the Study and Prevention of HIV/AIDS
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fortified beverage
Arm Type
Experimental
Arm 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.
Arm Title
Group receiving lactose-free milk
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Beverage fortified with 21 vitamins and minerals
Other Intervention Name(s)
Chispuditos®
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactose-free milk
Other Intervention Name(s)
High nutritive value vegetable mix
Intervention Description
Serving contains 4 grs. of protein, 12 grs of carbohydrate and 1 gr of fat
Primary Outcome Measure Information:
Title
Change in Nutritional status
Description
weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance
Time Frame
Months 0, 3, 6, 9, 12 and 15 months
Secondary Outcome Measure Information:
Title
Iron Status
Description
Hemoglobin level and serum ferritin level
Time Frame
Months 0 and 16
Title
Zinc status
Description
serum zinc level
Time Frame
Months 0 and 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Alfonso
Phone
+502 42196935
Email
valfonso@apevihs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Reinhart
Organizational Affiliation
Mathile Institute
Official's Role
Study Chair
Facility Information:
Facility Name
APEVIHS
City
Retalhuleu
Country
Guatemala
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Alfonso
Phone
+502 42196935
Email
valfonso@apevihs.org
First Name & Middle Initial & Last Name & Degree
Victor Alfonso
12. IPD Sharing Statement
Citations:
PubMed Identifier
12036814
Citation
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.
Results Reference
result
Citation
Ministry of Social Health and Public Assistance et al. Micronutrient National Survey. Guatemala MSPAS 56pp. 2011
Results Reference
result
Citation
Ministry of Public Health and Social Assistance. Maternal Infant Health Survey. Guatemala, MSPAS, 634 pp. 2010
Results Reference
result
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Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children
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