An interventional study of vitamin A supplementation in Vitamin A Deficiency, sponsored by Centre for Food and Nutrition Research, Yaounde. Completed. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2017-12-26.
Sponsored by Centre for Food and Nutrition Research, Yaounde · Not applicable, Interventional, and Treatment
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.
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.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 104 is below the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →Centre for Food and Nutrition Research, Yaounde is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Vitamin A status assessed at Baseline and one month after the administration of 200,000 IU of vitamin A
Dietary Supplement: vitamin A supplementation
Vitamin A status assessed at Baseline and three months after the administration of 200,000 IU of vitamin A
Dietary Supplement: vitamin A supplementation
Each child received one capsule of 200,000 IU of vitamin A
Change in vitamin A status at one month
Change from Baseline vitamin A total body stores at one month
Time frame: 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
Time frame: 3 months after vitamin A supplementation
No study locations are listed for this record.
Ran from Oct 2015 to primary completion in Mar 2016, 5 months.
Of 19 interventional studies with no phase under Vitamin A Deficiency, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Centre for Food and Nutrition Research, Yaounde