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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
Centre for Food and Nutrition Research, Yaounde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin A Deficiency

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 16, 2017
    Last Updated
    December 19, 2017
    Sponsor
    Centre for Food and Nutrition Research, Yaounde
    Collaborators
    International Atomic Energy Agency
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    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

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

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