| CTRI Number |
CTRI/2015/01/005392 [Registered on: 13/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
09/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of supplementation with Vitamin D on the sugar control of diabetic patients |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial of the effect of vitamin D3 supplementation on long term glycemic control |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaheen Chowdhury |
| Designation |
Post Graduate DNB Family Medicine |
| Affiliation |
Bangalore Baptist hospital |
| Address |
Department of Community Medicine and Family Medicine
Bangalore Baptist Hospital
Bellary Road Hebbal
Bangalore
Bellary Road hebbal Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
8971988347 |
| Fax |
|
| Email |
shaheenchowdhury@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gift Norman |
| Designation |
HOD Department of community health and family medicine |
| Affiliation |
Bangalore Baptist hospital |
| Address |
Department of Community Medicine
Bangalore Baptist Hospital
Bellary Road Hebbal
Bangalore
Bellary Road hebbal Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
8971988347 |
| Fax |
|
| Email |
normangift@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaheen Chowdhury |
| Designation |
Post Graduate DNB Family Medicine |
| Affiliation |
Bangalore Baptist hospital |
| Address |
Department of Community Medicine and Family Medicine
Bangalore Baptist Hospital
Bellary Road Hebbal
Bangalore
Bellary Road hebbal Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
8971988347 |
| Fax |
|
| Email |
shaheenchowdhury@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Baptist Hospital |
|
|
Primary Sponsor
|
| Name |
Bangalore Baptist Hospital |
| Address |
Bangalore Baptist Hospital
Bellary Road Hebbal
Bangalore |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Community Health Bangalore baptist hospital |
Community Health Bangalore baptist hospital |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shaheen |
Bangalore Baptist hospital |
Department of Family Medicine and Department of Medicine
Bangalore Baptist Hospital
Bellary Road Hebbal
Bangalore
Bangalore
KARNATAKA |
8971988347
shaheenchowdhury@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Bangalore Baptist Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes mellitus type 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium carbonate |
Calcium carbonate powder 1 gram given once a month orally for 3 months |
| Intervention |
Cholecalciferol (Calcirol) |
60000 IU (1gram)administered orally once a month for 3 months
contains activated 7-dehydrocholesterol which undergoes further hydroxylations in the liver and kidneys to form Calcitriol ( 1,25-dihydroxyvitamin D3 ) |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Adults
2)Above the age of 35 yrs
3)Diagnosis of diabetes mellitus ie. fasting blood values more than 125mg/dl, random blood sugar values of 140 mg/dl or more OR on current anti- hyperglycemic treatment
4) HbA1c values in between 6.5% to 8 %
5) who are willing to participate in the study
6) Willing to undergo a repeat glycosylated Hb testing after a period of 3 months |
|
| ExclusionCriteria |
| Details |
People on Vitamin D supplementation previously for other indications.
Anaemic people or those on iron supplementation
Chronic renal or liver disease
Hyperparathyroidism
Renal calculi
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| percentage of change in HbA1c |
3 months after first dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| percentage of change in HbA1c in rural and urban settings |
3 months after first dose |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/05/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A
randomised double blind placebo controlled trial to study the effect of
supplementation of 60,000 units of cholecalciferol per month on
glycemic control in 96 diabetic patients at a single centre in South
India. The primary outcome variable is a change in
percentage of HbA1c at the end of 3 months. This
study attempts to study the role (if any) that Vitamin D has on glycemic
control in diabetics . If (as past
research suggests) Vitamin D plays a role in modifying the control of sugars in
the diabetic population it could prove to be a safe, cost effective and widely
applicable add- on to the current standard of care in Diabetes management
|