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

Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03383744
Enrollment
104
Registered
2017-12-26
Start date
2015-10-05
Completion date
2016-07-29
Last updated
2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin A Deficiency

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTvitamin A supplementation

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

Sponsors

International Atomic Energy Agency
CollaboratorOTHER_GOV
Centre for Food and Nutrition Research, Yaounde
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
No

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

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Change in vitamin A status at one monthOne month after vitamin A supplementationChange from Baseline vitamin A total body stores at one month
Change in vitamin A status at 3 months3 months after vitamin A supplementationChange from Baseline vitamin A total body stores at 3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026