MedDataX Logo

Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.

NCT ID: NCT01751009

Last Updated: 2012-12-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study tried to prove that children given food supplements containing vitamin A would have better liver vitamin A stores than children given food supplements without vitamin A over a 5 month period.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study wanted to assess the effect of fortification of home based complementary foods on vitamin A status in Ghanaian children who receive food supplements known as Sprinkles. The study assessed the vitamin A status and body pool size in children using a test known as the modified relative dose response test (MRDR) tests and stable 13C2 retinol as a tracer, among those who receive Sprinkles with or without vitamin A through home fortification of complementary foods.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

vitamin A, complementary foods, malnutrition, children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin A supplements

Sprinkles with Vitamin A

Group Type EXPERIMENTAL

Vitamin A supplements

Intervention Type DIETARY_SUPPLEMENT

Sprinkles with Vitamin A

Sprinkles without Vitamin A

Made of other micronutrients without Vitamin A

Group Type ACTIVE_COMPARATOR

Sprinkles without Vitamin A

Intervention Type DIETARY_SUPPLEMENT

Active comparator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin A supplements

Sprinkles with Vitamin A

Intervention Type DIETARY_SUPPLEMENT

Sprinkles without Vitamin A

Active comparator

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Informed consent of mother of eligible children aged 6-12 months.

Willingness to remain in the study area for entire duration of the study.

Willingness to agree to feed the child with supplied micronutrient supplements for duration of study.

The child should have started taking complementary foods in addition to breast milk.

Child's haemoglobin level of at least 70 g/L.

Exclusion Criteria

Child's haemoglobin level less than 70 g/L.

Unable to give informed consent
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Wisconsin, Madison

OTHER

Sponsor Role collaborator

Kintampo Health Research Centre, Ghana

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sherry Tanumihardjo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kintampo North Municipality

Kintampo, , Ghana

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ghana

Related Links

Access external resources that provide additional context or updates about the study.

http://www.kintampo-hrc.org

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IORG0004854

Identifier Type: -

Identifier Source: org_study_id