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Using Stable Isotopes to Assess the Effectiveness of Vitamin A Supplementation in Cameroon

NCT ID: NCT03383744

Last Updated: 2017-12-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-05

Study Completion Date

2016-07-29

Brief Summary

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This is a study to evaluate the effects of vitamin A supplementation program on the vitamin A status of preschool children. All children aged 3-5 years who do not have severe illness and are not planning to move from the study area are eligible. Children whose caregivers agree to sign the consent form will be enrolled in their community and submitted to a longitudinal evaluation of vitamin A status before and after vitamin A supplementation campaign.

Vitamin A status will be assessed by measuring serum retinol, retinol binding protein and vitamin A total body pool size using stable isotope dilution methodology.

Detailed Description

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Five months after the last supplementation (day 0), an oral dose (2 mg retinol equivalents) of label vitamin A (\[2H8\]-retinyl acetate) in oil will be administered to 80 eligible children together with a low vitamin A high-fat snack. Fasting venous blood samples (about 7 ml) will be collected into evacuated foil-wrapped blood collection tubes specifically designed for the collection of serum (containing no anticoagulant and metal free) on the mornings of days 0 before the administration of the dose and on day 14 for quantitative estimation of initial vitamin A pool size and determination of potential confounding parameters (CRP, AGP, iron, zinc, malaria, carotenoids and retinoids). About six months after the last supplementation (day 30), each child will received the vitamin A supplement. After 30 days and 90 days, two groups of 40 children (Grp1, Grp2) will respectively received a second dose of labeled vitamin A (\[2H4\]-retinyl acetate); fasting venous blood samples will be obtained before the administration of the dose and 14 days after dosing for quantitative estimation of final vitamin A pool size and determination of potential confounding parameters.

Conditions

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Vitamin A Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

n subjects received the treatment and then randomly divided in two groups for outcome evaluation after one and three months respectively
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin A supplementation 1

Vitamin A status assessed at Baseline and one month after the administration of 200,000 IU of vitamin A

Group Type EXPERIMENTAL

vitamin A supplementation

Intervention Type DIETARY_SUPPLEMENT

Each child received one capsule of 200,000 IU of vitamin A

Vitamin A supplementation 3

Vitamin A status assessed at Baseline and three months after the administration of 200,000 IU of vitamin A

Group Type EXPERIMENTAL

vitamin A supplementation

Intervention Type DIETARY_SUPPLEMENT

Each child received one capsule of 200,000 IU of vitamin A

Interventions

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vitamin A supplementation

Each child received one capsule of 200,000 IU of vitamin A

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Children will be included if they are in the target age range (36-59 months), are not planning to move from the study area for the duration of the study and do not have severe illness at the time of enrolment
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Atomic Energy Agency

OTHER_GOV

Sponsor Role collaborator

Centre for Food and Nutrition Research, Yaounde

OTHER_GOV

Sponsor Role lead

Responsible Party

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Medoua Nama Gabriel

Head of Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Imdad A, Mayo-Wilson E, Haykal MR, Regan A, Sidhu J, Smith A, Bhutta ZA. Vitamin A supplementation for preventing morbidity and mortality in children from six months to five years of age. Cochrane Database Syst Rev. 2022 Mar 16;3(3):CD008524. doi: 10.1002/14651858.CD008524.pub4.

Reference Type DERIVED
PMID: 35294044 (View on PubMed)

Other Identifiers

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CMR_RAF6047

Identifier Type: -

Identifier Source: org_study_id