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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin A Deficiency
• Intervention / Treatment: Dietary supplement: vitamin A supplementation

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vitamin A supplementation 1; Vitamin A status assessed at Baseline and one month 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
EXPERIMENTAL: Vitamin A supplementation 3; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Centre for Food and Nutrition Research, Yaounde
• Collaborators: International Atomic Energy Agency

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 5, 2015
• Primary Completion (ACTUAL): March 23, 2016
• Study Completion (ACTUAL): July 29, 2016

Study Registration Dates

• First Submitted: December 16, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (ACTUAL): December 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vision Disorders; Night Blindness; Vitamin A Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: CMR_RAF6047

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No