Comparison of the Effect of Two Treatments on the Nutritional and Micronutrient Status of Malnourished Children
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ClinicalTrials.gov Identifier: NCT01643187 |
Recruitment Status
: Unknown
Verified July 2012 by Victor Alfonso Mayen, Association for the Study and Prevention of HIV/AIDS.
Recruitment status was: Not yet recruiting
First Posted
: July 18, 2012
Last Update Posted
: July 18, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malnutrition | Dietary Supplement: Beverage fortified with 21 vitamins and minerals Dietary Supplement: Lactose-free milk | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | July 2012 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

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.
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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®
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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.
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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
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- Change in Nutritional status [ Time Frame: Months 0, 3, 6, 9, 12 and 15 months ]weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance
- Iron Status [ Time Frame: Months 0 and 16 ]Hemoglobin level and serum ferritin level
- Zinc status [ Time Frame: Months 0 and 16 ]serum zinc level

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Ages Eligible for Study: | 6 Months to 72 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643187
Contact: Victor Alfonso | +502 42196935 | valfonso@apevihs.org |
Guatemala | |
APEVIHS | Not yet recruiting |
Retalhuleu, Guatemala | |
Contact: Victor Alfonso +502 42196935 valfonso@apevihs.org | |
Principal Investigator: Victor Alfonso |
Study Chair: | Gregory Reinhart | Mathile Institute |
Publications of Results:
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 |
First Posted: | July 18, 2012 Key Record Dates |
Last Update Posted: | July 18, 2012 |
Last Verified: | July 2012 |
Additional relevant MeSH terms:
Malnutrition Nutrition Disorders Vitamins Micronutrients |
Trace Elements Growth Substances Physiological Effects of Drugs |