Comparison between the efficacy of administering a dose of 50,000 weekly vitamin D supplements and 4,000 units of daily vitamin D supplementation in patients with chronic lymphocytic leukemia
Design
Clinical trials without control group, parallel group, double-blind, randomized trials
Settings and conduct
Double-blind study is done on patients referred to the Velayat hospital of Qazvin. Patients with chronic lymphocyte leukemia with vitamin D level less than 30 entering to the study after obtaining informed consent; and then are assigned to two groups by sealed envelope method. The first group receives daily 4000 units and the second group receives weekly 50000 units vitamin D for 3 months; and after 6 months the serum vitamin D level of the patients is measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with chronic lymphocyte leukemia that serum levels of vitamin D are less than 30
Exclusion criteria: hepatic failure, renal failure, vitamin D supplements during the last three months
Intervention groups
First group: Receive daily 4000 units vitamin D for 3 months
Second group: Receive weekly 50000 units vitamin D for 3 months
Main outcome variables
Patient' tolerance to the dose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180912041010N1
Registration date:2018-09-16, 1397/06/25
Registration timing:prospective
Last update:2018-09-16, 1397/06/25
Update count:0
Registration date
2018-09-16, 1397/06/25
Registrant information
Name
Yazdan Zafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 0620
Email address
y.zafari@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-31, 1397/08/09
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing theVitamin-D level treatment with 50000IU weekly Vitamin D and 4000IU daily Vitamin-D in Chronic lymphocytic leukemia patients
Public title
A weekly dose comparison of 5000 units of vitamin D supplementation with a daily dose of 4,000 units in patients with chronic leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic lymphocyte leukemia with a serum level of vitamin D of less than 30
Exclusion criteria:
Hepatic failure
Renal failure
Get Vitamin D supplementation in the last three months
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and patient are kept blind to the treatment assignment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Qazvin, Minoodar area, 22 Bahman BLVD.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2018-04-17, 1397/01/28
Ethics committee reference number
IR.QUMS.REC.1397.055
Health conditions studied
1
Description of health condition studied
Chronic lymphocytic leukemia
ICD-10 code
C91.7
ICD-10 code description
Other lymphoid leukaemia
Primary outcomes
1
Description
Patient tolerance to the dose
Timepoint
6 months after intervention
Method of measurement
Vitamin D Serum level in the blood sample
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receive daily 4000 units vitamin D for 3 months
Category
Treatment - Drugs
2
Description
Intervention group: Receive weeky 5000 vitamin D units for 3 months