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

Vitamin A Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383744
• Other study ID #: CMR_RAF6047
• Status: Completed
• Phase: N/A
• First received: December 16, 2017
• Last updated: December 19, 2017
• Start date: October 5, 2015
• Est. completion date: July 29, 2016

Study information

• Verified date: December 2017
• Source: Centre for Food and Nutrition Research, Yaounde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 29, 2016
• Est. primary completion date: March 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency

Intervention

Dietary Supplement:
• vitamin A supplementation
Each child received one capsule of 200,000 IU of vitamin A

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Food and Nutrition Research, Yaounde	International Atomic Energy Agency

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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