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

NCT03383744 | Completed DMC

• 1 other identifier: CMR_RAF6047
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vitamin A Deficiency

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Vitamin A supplementation 1

EXPERIMENTAL

Vitamin A status assessed at Baseline and one month after the administration of 200,000 IU of vitamin A

Dietary Supplement: vitamin A supplementation

Vitamin A supplementation 3

EXPERIMENTAL

Vitamin A status assessed at Baseline and three months after the administration of 200,000 IU of vitamin A

Dietary Supplement: vitamin A supplementation

Interventions

vitamin A supplementation DIETARY_SUPPLEMENT

Each child received one capsule of 200,000 IU of vitamin A

Vitamin A supplementation 1; Vitamin A supplementation 3

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Centre for Food and Nutrition Research, Yaounde: lead
• International Atomic Energy Agency: collaborator

Related Publications (1)

• 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.

  PMID: 35294044 DERIVED

MeSH Terms

Conditions

Vitamin A Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Centre

Model Details: n subjects received the treatment and then randomly divided in two groups for outcome evaluation after one and three months respectively

Study Record Dates

• First Submitted: December 16, 2017
• First Posted: December 26, 2017
• Study Start: October 5, 2015
• Primary Completion: March 23, 2016
• Study Completion: July 29, 2016
• Last Updated: December 26, 2017

Record last verified: 2017-12