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

Not Applicable

Completed

• Conditions: Vitamin A Deficiency
• Interventions: Dietary Supplement: vitamin A supplementation

• Registration Number: NCT03383744
• Lead Sponsor: Centre for Food and Nutrition Research, Yaounde

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.

Study Timeline

• Study Start: 2015-10-05
• Primary Completion: 2016-03-23
• Study Completion: 2016-07-29
• Status Verified: 2017-12
• Study First Submitted: 2017-12-16
• Study First Submitted QC: 2017-12-19
• Last Update Submitted: 2017-12-19
• Study First Posted: 2017-12-26
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Exclusion criteria will generally include the following conditions: severe anaemia, severe acute malnutrition, obesity, or clinically defined severe illness, such as dehydration, severe diarrhoea, malaria or severe respiratory illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin A supplementation 1	vitamin A supplementation	Vitamin A status assessed at Baseline and one month after the administration of 200,000 IU of vitamin A
Vitamin A supplementation 3	vitamin A supplementation	Vitamin A status assessed at Baseline and three months after the administration of 200,000 IU of vitamin A

Primary Outcome Measures

Name	Time	Method
Change in vitamin A status at one month	One month after vitamin A supplementation	Change from Baseline vitamin A total body stores at one month
Change in vitamin A status at 3 months	3 months after vitamin A supplementation	Change from Baseline vitamin A total body stores at 3 months