Vitamin-A status in tuberculous children

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201711002800419
• Date of registration: 27/11/2017
• Prospective Registration: No
• Primary sponsor: Division of Human Health International Atomic Energy Agency
• Public title: Vitamin-A status in tuberculous children
• Scientific title: Optimizing the Stable Isotope Dilution Technique to Assess Total Body Vitamin A Stores in the Context of TB Infection in Moroccan children.
• Date of first enrolment: 03/01/2016
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2800
• Study type: Interventional
• Study design: Crossover: all participants receive all interventions in different sequence during study,Randomised,Simple randomisation using by using procedures such as coin-tossing or dice-rolling,Numbered containers
• Phase: Not Applicable

Countries of recruitment

Morocco

Contacts

• Name: AGUENAOU HASSAN
• Affiliation: Head of RDC-Nutrition

• Name: BELGHITI HAKIM
• Affiliation: Physician

Key inclusion & exclusion criteria

Inclusion criteria: - Patient presenting a confirmed diagnosis of tuberculosis.
- Patients aged 3 to 17 years old
Exclusion criteria: - Patients affected by an acute or chronic disease other than the tuberculosis
- Subject having been under corticosteroid therapy during the last 3 months
- Children having received a supplementation of vitamin A during the last 6 months

Age minimum: 3 Year(s)
Age maximum: 17 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Tuberculosis

Intervention(s)

administration of Vitamin A labelled with 13C

administration of Vitamin A labelled with 8 deuterium

Primary Outcome(s)

Measuring the status of vitamin A in tuberculosis children

Secondary Outcome(s)

A. Determination of the TB effect on the terminal slope (K). B. To estimate the effects of the acute phase proteins (CRP, AGP) and tuberculosis on indicators of vitamin A status (serum retinol, RBP, total body stores and liver stores) in the case of acute infection in the hospital environment. C. The effect of infection on a different isotope compound with a mass difference of 8 and 2.

Secondary ID(s)

RAF6/047 - CRPE43030

Source(s) of Monetary Support

Division of Human Health International Atomic Energy Agency

Secondary Sponsor(s)

Unité Mixte de Recherche en Nutrition et Alimentation

Ethics review

Status: Approved
Approval date: 03/02/2015
Contact:

Comité d¿Ethique pour la Recherche Biomédicale