| CTRI Number |
CTRI/2014/12/005290 [Registered on: 15/12/2014] Trial Registered Prospectively |
| Last Modified On: |
14/12/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Vitamin D3 Supplementation On Level Of Blood Glucose Among Vitamin D Deficient Adult With Prediabetes. |
|
Scientific Title of Study
|
A Study To Assess The Effect Of Vitamin D3 Supplementation On Level Of Blood Glucose Among Vitamin D Deficient Adult With Prediabetes. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A Rathiga |
| Designation |
Professor |
| Affiliation |
Chettinad Academy of Research and education |
| Address |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION
CHETTINAD COLLEGE OF NURSING,
IT HIGH WAY
KELAMBAKKAM
KANCHEEPURAM DISTRICT
TAMILNADU 603 103
INDIA
No.4, Arcot Road
1-M Jamals Splendor
Porur
Chennai 600 116
TamilNadu
Chennai
TAMIL NADU
603 103
India |
| Phone |
09791025299 |
| Fax |
|
| Email |
dhiya.rathiga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A Rathiga |
| Designation |
Professor |
| Affiliation |
Chettinad Academy of Research and education |
| Address |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION
CHETTINAD COLLEGE OF NURSING,
IT HIGH WAY
KELAMBAKKAM
KANCHEEPURAM DISTRICT
TAMILNADU 603 103
INDIA
No.4, Arcot Road
1-M Jamals Splendor
Porur
Chennai 600 116
TamilNadu
Chennai
TAMIL NADU
603 103
India |
| Phone |
09791025299 |
| Fax |
|
| Email |
dhiya.rathiga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A Rathiga |
| Designation |
Professor |
| Affiliation |
Chettinad Academy of Research and education |
| Address |
CHETTINAD ACADEMY OF RESEARCH AND EDUCATION
CHETTINAD COLLEGE OF NURSING,
IT HIGH WAY
KELAMBAKKAM
KANCHEEPURAM DISTRICT
TAMILNADU 603 103
INDIA
No.4, Arcot Road
1-M Jamals Splendor
Porur
Chennai 600 116
TamilNadu
Chennai
TAMIL NADU
603 103
India |
| Phone |
09791025299 |
| Fax |
|
| Email |
dhiya.rathiga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Affiliated institute for this study |
| This is investigator initiated trail.The Principal investigator is the primary sponsor through the affiliated institution |
|
|
Primary Sponsor
|
| Name |
A Rathiga |
| Address |
1M, Jamals splendor, Arcot road chennai |
| Type of Sponsor |
Other [Principal investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| A Rathiga |
Medical OPD and Master health checkup department in chettinad Hospital and research Institute |
IT Highway, Kelambakkam
Kancheepuram
TAMIL NADU |
09791025299
dhiya.rathiga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad Academy of Research and Education Institutional Human Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Vitamin D deficient Adult with prediabetes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
For Group 2 (Control group)vitamin D deficient adult with prediabetes observe the patient and withhold the treatment |
First phase assess all the parameters and 16th week assess the post test |
| Intervention |
For group I (Intervention group) supplementation of vitamin D3 (Cholecalciferol) among vitamin D deficient adult with prediabetes |
Oral supplementation of vitamin D3(Cholecalciferol) 60,000IU/week for 8 weeks followed by 60,000IU/month for 2months to achieve the serum vitamin D 50ng/dl and post test evaluation will be done on 16 th week |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject who belongs to
 age 30 years up to 60 years
 individuals who met the diabetes risk score criteria
 both male and female
 fasting plasma glucose level 110 to 125 mg/dl
 Oral glucose tolerance test 140 to 199mg/dl.
 vitamin D3 below 30ng/dl
|
|
| ExclusionCriteria |
| Details |
Subjects who with
diabetes under medication
currently using vitamin D supplements
hypercalcaemia above 2.65mmol/l
liver disease, Virus or autoimmune hepatitis and cirrhosis
history of hyperparathyroidism
history of arthritis
history of Pulmonary Tuberculosis
history of malabsorption
Pregnant women
History of chronic renal failure, nephrotic syndrome, Renal stone hypothyroidism, and HIV patients on antiviral drugs.
History of malignant diseases
History of inflammatory diseases
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
25 hydroxy vitamin d3 reach 50 or above 50 ng/dl
Blood glucose level 80 to 100 mg/dl
|
Oral supplementation of vitamin D3(Cholecalciferol) 60,000IU/week for 8 weeks followed by 60,000IU/month for 2months to achieve the serum vitamin D 50ng/dl and post test evaluation will be done on 16 th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Vitamin d 3 supplementation Effect on Insulin resistance and
Effect on triglyceride
|
Oral supplementation of vitamin D3(Cholecalciferol) 60,000IU/week for 8 weeks followed by 60,000IU/month for 2months to achieve the serum vitamin D 50ng/dl and post test evaluation will be done on 16 th week |
|
|
Target Sample Size
|
Total Sample Size="288"
Sample Size from India="288"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/01/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 randomized controlled trail proposed to conduct on to assess the effect of vitamin d3 supplementaion on level of blood glucose among vitamin D deficient adult with prediabetes among 288 samples in selected teritary hospital, kanchhepuram. The primary outcome of the study will be selected subject will maintain the vitamin d level 50 or above 50 ng/dl and blood glucose level 80 to 100 mg/dl as per the who criteria.
|