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.: PACTR201811682685226 Date of Approval: 23/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Vitamin D supplementation
Official scientific title Vitamin D status and Vitamin D Supplementation in asthmatic children
Brief summary describing the background and objectives of the trial Asthma is a major public health. there has been great arouses of interest in the prescription of vitamin D supplementation as a valuable therapeutic choice, in order to maintain long-term remission and prevent further exacerbation and decline in lung functioning. patients with serum vitamin D level <30 ng/ml were asked to receive oral vitamin d3 (cholechalceferol) syrup (1000IU/D) for 2 months duration, as an add on therapy to their current antiasthma medications. The compliance of the patient was evaluated by weekly visits.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 31/07/2018
Actual trial start date 31/07/2018
Anticipated date of last follow up 01/11/2018
Actual Last follow-up date 01/11/2018
Anticipated target sample size (number of participants) 29
Actual target sample size (number of participants) 29
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Vitamin D supplementation (1000 IU daily dose) oral syrup Two month Vitamin D supplement for two months (1000 IU daily dose) 29
Experimental Group Vitamin D 1000 IU daily dose Two month Oral syrup of vitamin Dsupplementation 29
Control Group Vitamin D (1000 IU daily dose) Two month Vitamin D supplement 29 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Vitamin d serum level less than 30 ng/l Reciving vitamin supplement in the previous 6 month Child: 6 Year-12 Year 6 Year(s) 12 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 01/11/2017 National research center medical research ethical committie
Ethics Committee Address
Street address City Postal code Country
Elbohoth Cairo 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pulmonary function readings (FVC, FVC1) Two month
Secondary Outcome childhood ACT questionnaire total score Two month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National research center Elbohoth street -dokki -Egypt Cairo 12623 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National research center Elbohoth Cairo 12622 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Ein shams university Elbohoth Cairo 12622 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ola Mostafa olamibrahim@hotmail.com +2023337093 Elbohoth
City Postal code Country Position/Affiliation
Cairo 12622 Egypt Professor
Role Name Email Phone Street address
Public Enquiries Mai Elsoudy mai.seoudy@yahoo.com +2023337093 Elbohoth
City Postal code Country Position/Affiliation
Cairo 12662 Egypt Researcher
Role Name Email Phone Street address
Scientific Enquiries Sara Fawzy lara26sara@yahoo.com +2023337093 Elbohoth
City Postal code Country Position/Affiliation
Cairo 12662 Egypt Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes After two months of vitamin D supplementation -The serum vitamin D level increased significantly after 2 months’ when compared with the baseline of the asthmatic patients. VDR expression decreased after 2-month supplementation with Vit D. - the childhood ACT questionnaire total score, GINA level of control as well as the pulmonary function readings (FVC, FVC1) showed statistically significant improvement after completion of Vit D supplementation for 2 months 31/12/2018 20/03/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://doi.org/10.1016/j.genrep.2019.100387
Changes to trial information