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

Study Overview
=================
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.

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

Conditions
-----------------
Vitamin A Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin A supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: n subjects received the treatment and then randomly divided in two groups for outcome evaluation after one and three months respectively
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin A supplementation 1<br>Vitamin A status assessed at Baseline and one month after the administration of 200,000 IU of vitamin A | Dietary Supplement: vitamin A supplementation<br>* Each child received one capsule of 200,000 IU of vitamin A<br>|
| Experimental: Vitamin A supplementation 3<br>Vitamin A status assessed at Baseline and three months after the administration of 200,000 IU of vitamin A | Dietary Supplement: vitamin A supplementation<br>* Each child received one capsule of 200,000 IU of vitamin A<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vitamin A status at one month | Change from Baseline vitamin A total body stores at one month | One month after vitamin A supplementation | 
| Change in vitamin A status at 3 months | Change from Baseline vitamin A total body stores at 3 months | 3 months after vitamin A supplementation |