Vitamin A Deficiency Clinical Trial
Official title:
Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03353662 -
Sub Regional Micronutrient Survey in Ethiopia
|
||
Completed |
NCT01061307 -
An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand
|
Phase 0 | |
Completed |
NCT00082420 -
Retinol Equivalence of Plant Carotenoids in Children
|
N/A | |
Recruiting |
NCT04438200 -
Liver and Bone Retinol Levels in Guatemalan Adolescents and Adults
|
||
Not yet recruiting |
NCT06450925 -
Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
|
N/A | |
Completed |
NCT02996513 -
Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method
|
N/A | |
Completed |
NCT02027610 -
Vitamin A, Stool Microbiota and Vaccine Response in Bangladeshi Infants
|
N/A | |
Completed |
NCT01922713 -
Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women
|
N/A | |
Completed |
NCT02043223 -
Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit
|
Phase 2/Phase 3 | |
Completed |
NCT05882682 -
Impact of Food-to-Food Fortified Cereal Products on Diet Quality in Eldoret, Kenya
|
||
Completed |
NCT04632771 -
Nutritional Status and Bouillon Use in Northern Ghana
|
||
Completed |
NCT02760095 -
Effects of EED on Zn Absorption and Retention in Children From a Standard Dose
|
||
Active, not recruiting |
NCT01476358 -
Effect of Vitamin A Supplementation on Immune Responses in Human Neonates
|
Phase 2 | |
Completed |
NCT04137354 -
Iron and Vitamin A in School Children
|
N/A | |
Completed |
NCT00198718 -
Single-dose Postpartum Vitamin A Supplementation of Mothers and Neonates
|
Phase 2 | |
Not yet recruiting |
NCT04127968 -
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis
|
N/A | |
Completed |
NCT03640104 -
Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores
|
N/A | |
Completed |
NCT01614483 -
Efficacy of Yellow Cassava to Improve Vitamin A Status of Kenyan School Children
|
N/A | |
Completed |
NCT02702622 -
Vitamin A Equivalence of the Provitamin A in Biofortified Bananas
|
N/A | |
Completed |
NCT02804490 -
Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
|
Phase 3 |