Home » Trials » SLCTR/2018/020
A Randomized Control Trial comparing vitamin D supplementation versus placebo on glycemic control in gestational diabetes mellitus
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SLCTR Registration Number
SLCTR/2018/020
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A Randomized Control Trial comparing vitamin D supplementation versus placebo on glycemic control in gestational diabetes mellitus
Public Title of Trial
A randomized controlled clinical trial to compare the efficacy of Vitamin D vs placebo to reduce high blood sugar during pregnancy
Disease or Health Condition(s) Studied
Gestational diabetes
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1199-1547
Any other number(s) assigned to the trial and issuing authority
(Ref. No. P/277/12/2017: ERC Kelaniya)
What is the research question being addressed?
Is there an effect of Vitamin D on improving glycemic control in gestational diabetes?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study site is the antenatal clinic of the Colombo North Teaching Hospital, Ragama.
Block randomization will be done using a computer generated sequence using a web based application. Block size has been taken as 6. The generated sequence will be concealed with sealed envelope method. Recruitment of participants and the allocation will be done by two different medical officers leading to allocation concealment.
Alfacalcidol 0.25 microgram capsule will be given to the intervention arm once a day orally as Vitamin D supplementation for a period of 4 weeks.
Folic acid 1 mg tablet will be given once a day orally for the control arm as placebo for a period of 4 weeks.
In addition, folic acid 1 mg tablet once day orally will be given to both groups as it is the standard antenatal practice of Sri Lanka (The control arm will receive this folic acid treatment on top of the placebo treatment).
During the trial period blood sugar will be routinely monitored and fetal monitoring will be carried out. If a participant needs to be started on insulin according to blood sugar measurements, they will be dropped from the trial and insulin treatment will be initiated.
Outcomes will be measured only in participants who still remain within inclusion criteria after completion of the trial.
If patients are removed due to adverse effects of Vitamin D it will be specifically reported in the conclusion and will also be reported to the National Medicines Regulatory Authority.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
The mean difference of blood glucose levels in the two arms before and after the intervention. Blood glucose levels will be measured by fasting blood sugar (FBS) test and 1hour post prandial blood sugar (PPBS) (post breakfast) test |
[ Day1 (before the intervention) and after 4 weeks of intervention. ] |
Secondary outcome(s)
|
1.
Any difference of occurrence of the following |
[
|
Target number/sample size
48 (24 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-07-01
Anticipated end date
2018-10-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Status
Approved
Date of Approval
2018-04-10
Approval number
P/277/12/2017
Details of Ethics Review Committee
| Name: | 5. Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Tharaka Sandaruwan
Registrar
Colombo North Teaching Hospital,
Ragama
0772381887
tarakasanda@gmail.com
Contact Person for Public Queries
Dr. Carmeline Motha
Consultant Physician
Ward 24/25
Colombo North Teaching Hospital, Ragama
0714492904
carmelinemotha@kln.ac.lk
Primary study sponsor/organization
Colombo North Teaching Hospital
Hospital Inner Road, Ragama 11010
Tel: 0112960023 0112960523
http://www.cnth.health.gov.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
