Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201711002800419 Date of Approval: 27/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Vitamin-A status in tuberculous children
Official scientific title Optimizing the Stable Isotope Dilution Technique to Assess Total Body Vitamin A Stores in the Context of TB Infection in Moroccan children.
Brief summary describing the background and objectives of the trial In Morocco, vitamin A (VA) deficiency among children is a public health problem. In 2008, 22.7% of children aged 3 to 6 years were VA deficient (retinol level <200µg/L). To combat this problem four strategies have been adopted: - Nutritional education; - VA supplementation; - food fortification and - public health measures which include programs aiming to improve the health of the population (the national immunization program, the program to combat acute respiratory infections, the program to fight diarrhea, the program to combat tuberculosis (TB), the program to promote breastfeeding... Since 2011, Morocco developed its own national strategy for nutrition 2011-2019 which included all the above mentioned programs in an integrated approach. In Morocco, the National Survey on Population and Family Health in 2011 showed that 21.7% had respiratory problems. For TB and among children, 1030 cases were reported during 2015. The evaluation of VA status is relatively insensitive when based on serum retinol which is homeostasis controlled and negatively affected by subclinical infections. The isotope dilution technique is the preferred method for determining VA status and assessing the efficiency and effectiveness of intervention programs aimed to improve VA status. It is the only indirect assessment method that provides a quantitative estimate of VA status across the continuum from deficient to excessive VA. The main project aim is to estimate VA status in young children and teenagers with tuberculosis in Morocco using isotope dilution techniques. While the Specific objectives are -Determination of the TB effect on the terminal slope (K); -To estimate the effects of the acute phase proteins (CRP, AGP) and tuberculosis on indicators of VA status (serum retinol, RBP, total body stores and liver stores); -The effect of infection on a different isotope compound with a mass difference of 8 and 2.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TISSEAT
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 03/01/2016
Actual trial start date 04/09/2016
Anticipated date of last follow up 28/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 80
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
RAF6/047 - CRPE43030 IAEA
RAF6/047 - CRPE43030 IAEA
RAF6/047 - CRPE43030 IAEA
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group administration of Vitamin A labelled with 13C 1 ¿mol 1 time administration of Vitamin A labelled with 13C 50 Active-Treatment of Control Group
Experimental Group administration of Vitamin A labelled with 8 deuterium 6 ¿mol 1 time administration of Vitamin A labelled with 8 deuterium 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patient presenting a confirmed diagnosis of tuberculosis. - Patients aged 3 to 17 years old - 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 3 Year(s) 17 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/02/2015 Comité d¿Ethique pour la Recherche Biomédicale
Ethics Committee Address
Street address City Postal code Country
Université Mohammed V - Souissi Faculté de Médecine et de Pharmacie de Rabat Rabat 10001 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measuring the status of vitamin A in tuberculosis children February 2019
Secondary Outcome 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. February 2019
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pneumophysiology department of Moulay Youssef Hospital Avenue Sidi Mohamed Ben Abdaliah Rabat 10001 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
Division of Human Health International Atomic Energy Agency P.O. Box 100 Wagramer Strasse 5 Vienna 1400 Austria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Division of Human Health International Atomic Energy Agency P.O. Box 100 Wagramer Strasse 5 Vienna 1400 Austria Funding Agency
Secondary Sponsor Unité Mixte de Recherche en Nutrition et Alimentation Madinat Al Irfane Rabat 10001 Morocco University
COLLABORATORS
Name Street address City Postal code Country
Pneumophysiology department of Moulay Youssef Hospital Avenue Sidi Mohamed Ben Abdaliah Rabat 10001 Morocco
Clinical Nutrition department, Mohammed V Military Hospital of Instruction Hay Ryad Rabat 10001 Morocco
Neonatology Service at CHU Ibn Sina, Rabat Rue Lamfadel Cherkaoui Rabat 10001 Morocco
DELM, Ministère de la Santé 71, av Ibn Sina Rabat 10001 Morocco
Directorate of Population, Ministry of Health avenue Mohamed Belhassan Elouazzani, haut Agdal Rabat 10100 Morocco
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator EL KARI KHALID khalidelkari@yahoo.fr +212668283518 CNESTEN, Madinat Al Irfane
City Postal code Country Position/Affiliation
Rabat 10001 Morocco Head of Nutrition and Food Unit
Role Name Email Phone Street address
Public Enquiries BELGHITI HAKIM hakbelg@yahoo.fr +212661064034 Hopital d'Instruction Militaire MV
City Postal code Country Position/Affiliation
Rabat 10001 Morocco Physician
Role Name Email Phone Street address
Scientific Enquiries AGUENAOU HASSAN aguenaou2014@gmail.com +212663756730 Faculté des Science Université Ibn Tofail
City Postal code Country Position/Affiliation
Kénitra 14000 Morocco Head of RDC-Nutrition
REPORTING
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