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.: PACTR201803002999356 Date of Approval: 22/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title RAF 6047
Official scientific title Use of stable isotope techniques to monitor and assess the vitamin A status of children susceptible to infection
Brief summary describing the background and objectives of the trial According to the WHO (2005), approximately 13 million children die each year in developing countries from infectious diseases, with the majority of these deaths related to malnutrition. The relationship between infections and malnutrition is synergistic, each further compromising the outcome of the other. Malnutrition compromises natural immunity and in the other side,infections can aggravate or precipitate malnutrition. Severe malnutrition often masks symptoms and signs of infectious diseases making prompt clinical diagnosis and treatment very difficult. Another issue is that infections (as well as overweight and obesity status) affect nutritional biomarkers making it difficult to assess the real magnitude of some nutritional problems. This is the case of vitamin A.Vitamin A deficiency is the leading cause of preventable blindness in children and is associated with a higher mortality risk. Regarding the rule of vitamin A in human body, the current project which aim is to use nuclear techniques to evaluate vitamin A nutritional status of young children during semi-annual administration of vitamin A supplementations, and to assess how this relates to infection status has been suggested.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) RAF 6047
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Vitamin A status
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/08/2016
Actual trial start date 09/11/2016
Anticipated date of last follow up 30/05/2017
Actual Last follow-up date 23/09/2017
Anticipated target sample size (number of participants) 115
Actual target sample size (number of participants) 115
Recruitment status Completed
Publication URL NA
Secondary Ids Issuing authority/Trial register
N/Ref . A21- 2016 local ethical commettee
N° 2016 - 00226/ MS/ RHBS/DRS Regional Health direction (local health authority)
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vitamin A supplementation Single dose of 200000 UI vitamin A 01 month Use of C13 retinol de determine the vitamin A status 60 Uncontrolled
Control Group None NA NA NA 55 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Children of both sexes of 36-59 months aged; -Children living in the study area throughout the study period; -Children whose parents or legal guardian have signed a written informed consent form -Child with severe malnutrition (weight for height Z score below -3 SD, WHO growth standards); -Children with fever or a history of fever in the previous 24 hours (there is fever when the uncorrected axillary temperature is above 37.5 ° Celsius); -Children suffering from other serious illnesses which involved hospitalization 36 Month(s) 59 Month(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 12/07/2016 Institutional Ethics Committee for Health Sciences Research
Ethics Committee Address
Street address City Postal code Country
399 Street of freedom Bobo Dioulasso 545 Bobo Dioulasso Burkina Faso
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Vitamin A status of children from 36 to 59 months of age exposed to infections in rural Burkina Faso -During the dry season -During the rainy season -After vitamin A supplementation compaign
Secondary Outcome the effect of infections/ inflammation on vitamin A biomarkers -During the dry season -During the rainy season -Post vitamin A supplemention
Secondary Outcome Correlations between serum carotenoids and intake of vitamin A rich food in children During the dry season -During the rainy season -After vitamin A supplementation compaign
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut de recherche en sciences de la santé/ Direction regionale de l'Ouest 399 Street of freedom Bobo Dioulasso 545 Bobo Dioulasso Burkina Faso
FUNDING SOURCES
Name of source Street address City Postal code Country
International Atomic Energy Agency A-1400 Vienna Box 100, A-1400 Austria
International Atomic Energy Agency A-1400 Vienna Box 100 Austria
Institut de Recherche en Sciences de la Santé 399 Street of freedom Bobo Dioulasso 545 Bobo Dioulasso Burkina Faso
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Atomic Energy Agency A-1400 Vienna Box 100 Austria Funding Agency
Secondary Sponsor Institut de Recherche en Sciences de la Santé 399 Street of freedom Bobo Dioulasso 545 Bobo Dioulasso Burkina Faso University
COLLABORATORS
Name Street address City Postal code Country
University of Madison - Wisconsin (USA) 1415 Linden Drive Madison Box 53706 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zeba N. Augustin nawidzeb@yahoo.fr +22672168697 399 Street of the freedom
City Postal code Country Position/Affiliation
Bobo dioulasso Box 545 Burkina Faso Head of nutrition and metabolic diseases unit
Role Name Email Phone Street address
Public Enquiries Ouedraogo Jean Bosco jbouedraogo@gmail.com +22670354680 399 Street of the freedom
City Postal code Country Position/Affiliation
Bobo dioulasso Box 545 Burkina Faso Co principal investigator
Role Name Email Phone Street address
Scientific Enquiries Sombie O. Olivier sombieolivier@yahoo.fr +22670001526 399 Street of the freedom
City Postal code Country Position/Affiliation
Bobo dioulasso Box 545 Burkina Faso Physician
REPORTING
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Result URL Hyperlinks
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