NCT01643187

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

1.4 years

First QC Date

July 13, 2012

Last Update Submit

July 16, 2012

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Change in Nutritional status

    weight for height Z-score, height for age Z-score, weight for age Z-score and mid arm circumferance

    Months 0, 3, 6, 9, 12 and 15 months

Secondary Outcomes (2)

  • Iron Status

    Months 0 and 16

  • Zinc status

    Months 0 and 16

Study Arms (2)

Fortified beverage

EXPERIMENTAL

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

Group receiving lactose-free milk

ACTIVE COMPARATOR

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

Interventions

Beverage fortified with 21 vitamins and mineralsDIETARY_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.

Also known as: Chispuditos®
Fortified beverage
Lactose-free milkDIETARY_SUPPLEMENT

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

Also known as: High nutritive value vegetable mix
Group receiving lactose-free milk

Eligibility Criteria

Age6 Months - 72 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Some degree of malnutrition according to weight for height or height for age
  • Reside in one of the six communities chosen for the study

You may not qualify if:

  • Leukemia
  • Diabetes
  • Handicap
  • Down syndrome
  • Renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APEVIHS

Retalhuleu, Guatemala

Location

Related Publications (3)

  • 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.

    PMID: 12036814RESULT

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

    RESULT

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

    RESULT

MeSH Terms

Conditions

Malnutrition

Interventions

Minerals

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

  • Gregory Reinhart

    Mathile Institute

    STUDY CHAIR

Central Study Contacts

Victor Alfonso

CONTACT

+502 42196935valfonso@apevihs.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutritionist, Magister Science

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 18, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

GU(1)