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.: PACTR201803003160262 Date of Approval: 03/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of a six-week treatment course of vitamin D in steady state sickle cell anaemia children with hypovitaminosis
Official scientific title Comparative Effectiveness of six-week treatment course of vitamin D2 and D3 in children with sickle cell anaemia in steady state: A randomized clinical Trial
Brief summary describing the background and objectives of the trial A randomized clinical trial. A comparative study to determine the effectiveness of six-week treatment of hypovitaminosis in children with sickle cell anaemia using vitamin D2 and D2. The objectives are: To determine the difference in the mean serum rise of subjects treated with vitamin D2 and D3. Six-week treatment using 50,000IU weekly of vitamin D according to Endocrine society clinical practice guideline has been adopted for the study. Inclusion criteria includes confirmed Haemoglobin SS children aged one to eighteen years in steady state. Exclusion criteria are children on antituberculose drug, on anticonvulsants and with established liver or kidney disease. The study also aimed to also determine the effect of correction of hypovitaminosis on serum calcium and alkaline phosphatase.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Nutritional, Metabolic, Endocrine,Sickle cell anaemia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 11/03/2018
Actual trial start date 11/03/2018
Anticipated date of last follow up 31/05/2018
Actual Last follow-up date 31/05/2018
Anticipated target sample size (number of participants) 154
Actual target sample size (number of participants) 148
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NHREC04/04/2008 Health Research and Ethics Committee, Lagos State University Teaching Hospital, Ikeja
NHREC04/04/2008 Health Research and Ethics Committee, Lagos State University Teaching Hospital, Ikeja
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 randomization where equal number of D2 and D3 will be written on a sealed opaque envelopes. The number will be generated following initial analysis to determine the number of subjects with hypovitaminosis. Each subject will be given either D2 or D3 based on what is picked from the envelopes. Sealed opaque envelopes will be used. The drug will be given by a nurse who is not part of the study Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oral vitamin D2 50,000IU once a week 6 weeks correction of hypovitaminosis 74
Experimental Group oral vitamin D3 50,000IU once a week 6 weeks correction of hypovitaminosis 74
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with sickle cell anaemia aged 1 to 18 years Children with 25(OH)D level below 75nmol/L Children whose parents give consent Children 7 years and above that assent to be part of the study Children with established diagnosis of tuberculosis, asthma or on steroid Children with established renal or kidney disease Children on anticonvulsants 1 Year(s) 18 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 09/01/2018 Health Research and Ethics Committee, Lagos State University Teaching Hospital, Ikeja
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi Way, GRA, IKeja lagos PMB 21005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean rise in serum 25(OH)D following 6 weeeks treatment of hypovitaminosis after 6 weeks treatment of hypovitaminosis
Secondary Outcome Mean rise in serum calcium and alkaline phosphatase following 6 weeks correction of hypovitaminosis after 6 weeks of correction of hypovitaminosis
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sickle Cell Foundation Centre, Nigeria National Sickle Cell Centre, Opposite Lagos University Teaching Hospital, Ishaga Road, Idi-Araba, Lagos Lagos P.O Box 3463, Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Motunrayo Adekunle 4 Olu Akinsanya, GRA, Sagamu, Ogun State Sagamu P.O Box 19413,Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Prof. Olisamedua Fidelis Njokanma Department of Paediatrics, 1-5 Oba Akinjobi Way, GRA, IKeja, nigeria Lagos 100282 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Dr. Adaobi Uzuamaka Solarin Department of Paediatrics, 1-5 Oba Akinjobi Way, GRA, IKeja, nigeria Lagos 100282 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Motunrayo Adekunle motunbamm@yahoo.com (+234)08036000219 4 Olu Akinsanya Street, GRA, Sagamu
City Postal code Country Position/Affiliation
Sagamu 121101 Nigeria Consultant Paediatrician/ Lagos State University Teaching Hospital, Ikeja, Nigeria
Role Name Email Phone Street address
Public Enquiries Adaobi Solarin asolar234@yahoo.com (+234)08033041915 11, Samuel Ajayi Street, off Emmanuel Keshi, Magodo phase 2, Lagos
City Postal code Country Position/Affiliation
Lagos 100282 Nigeria Consultant Nephrologist/ Lagos State University Teaching Hospital, Ikeja
Role Name Email Phone Street address
Scientific Enquiries Olisamedua Njokanma faconj@yahoo.com 08060051717 8 Folasade Close, Off Falolu Street. Surulere, Lagos
City Postal code Country Position/Affiliation
PMB 21005 Nigeria Professor of Paediatrics, Lagos State University Teaching Hospital, Ikeja, Nigeria
REPORTING
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