Using Stable Isotopes to Assess the Effectiveness of Vitamin A Supplementation in Cameroon
Primary Purpose
Vitamin A Deficiency
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vitamin A supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin A Deficiency
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vitamin A supplementation 1
Vitamin A supplementation 3
Arm Description
Vitamin A status assessed at Baseline and one month after the administration of 200,000 IU of vitamin A
Vitamin A status assessed at Baseline and three months after the administration of 200,000 IU of vitamin A
Outcomes
Primary Outcome Measures
Change in vitamin A status at one month
Change from Baseline vitamin A total body stores at one month
Change in vitamin A status at 3 months
Change from Baseline vitamin A total body stores at 3 months
Secondary Outcome Measures
Full Information
NCT ID
NCT03383744
First Posted
December 16, 2017
Last Updated
December 19, 2017
Sponsor
Centre for Food and Nutrition Research, Yaounde
Collaborators
International Atomic Energy Agency
1. Study Identification
Unique Protocol Identification Number
NCT03383744
Brief Title
Using Stable Isotopes to Assess the Effectiveness of Vitamin A Supplementation in Cameroon
Official Title
Using Stable Isotope Techniques to Monitor and Assess the Vitamin A Status of Children Susceptible to Infection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 5, 2015 (Actual)
Primary Completion Date
March 23, 2016 (Actual)
Study Completion Date
July 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Food and Nutrition Research, Yaounde
Collaborators
International Atomic Energy Agency
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin A supplementation 1
Arm Type
Experimental
Arm Description
Vitamin A status assessed at Baseline and one month after the administration of 200,000 IU of vitamin A
Arm Title
Vitamin A supplementation 3
Arm Type
Experimental
Arm Description
Vitamin A status assessed at Baseline and three months after the administration of 200,000 IU of vitamin A
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin A supplementation
Intervention Description
Each child received one capsule of 200,000 IU of vitamin A
Primary Outcome Measure Information:
Title
Change in vitamin A status at one month
Description
Change from Baseline vitamin A total body stores at one month
Time Frame
One month after vitamin A supplementation
Title
Change in vitamin A status at 3 months
Description
Change from Baseline vitamin A total body stores at 3 months
Time Frame
3 months after vitamin A supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
35294044
Citation
Imdad A, Mayo-Wilson E, Haykal MR, Regan A, Sidhu J, Smith A, Bhutta ZA. Vitamin A supplementation for preventing morbidity and mortality in children from six months to five years of age. Cochrane Database Syst Rev. 2022 Mar 16;3(3):CD008524. doi: 10.1002/14651858.CD008524.pub4.
Results Reference
derived
Learn more about this trial
Using Stable Isotopes to Assess the Effectiveness of Vitamin A Supplementation in Cameroon
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