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

NCT ID: NCT01643187

Last Updated: 2012-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Beverage fortified with 21 vitamins and minerals

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type ACTIVE_COMPARATOR

Lactose-free milk

Intervention Type DIETARY_SUPPLEMENT

Serving contains 4 grs. of protein, 12 grs of carbohydrate and 1 gr of fat

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Lactose-free milk

Serving contains 4 grs. of protein, 12 grs of carbohydrate and 1 gr of fat

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Chispuditos® High nutritive value vegetable mix

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

72 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association for the Study and Prevention of HIV/AIDS

OTHER

Sponsor Role lead

Responsible Party

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Victor Alfonso Mayen

Nutritionist, Magister Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory Reinhart

Role: STUDY_CHAIR

Mathile Institute

Locations

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APEVIHS

Retalhuleu, , Guatemala

Site Status

Countries

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Guatemala

Central Contacts

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Victor Alfonso

Role: CONTACT

Phone: +502 42196935

Email: [email protected]

Facility Contacts

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Victor Alfonso

Role: primary

References

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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.

Reference Type RESULT
PMID: 12036814 (View on PubMed)

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

Reference Type RESULT

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

Reference Type RESULT

Other Identifiers

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APE-001

Identifier Type: -

Identifier Source: org_study_id