| CTRI Number |
CTRI/2024/01/061970 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effect of vitamin D3 supplementation on sleep quality in adults |
|
Scientific Title of Study
|
Assessment of the impact of Vitamin D3 supplementation on sleep quality in adults with vitamin D deficiency |
| Trial Acronym |
AVIDS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Priya |
| Designation |
Assistant Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Neurosciences,
First floor, Ramaiah Memorial hospitals,
Gokula, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
8903211566 |
| Fax |
|
| Email |
lalithapriya.68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Priya |
| Designation |
Assistant Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Neurosciences,
First floor,
Ramaiah Memorial Hospitals,
Gokula, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
8903211566 |
| Fax |
|
| Email |
lalithapriya.68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi Priya |
| Designation |
Assistant Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Neurosciences,
First floor,
Ramaiah Memorial Hospitals,
Gokula, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
8903211566 |
| Fax |
|
| Email |
lalithapriya.68@gmail.com |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical College and hospital,
New BEL Road,
Gokula, Bangalore 560054 |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College and Hospital |
| Address |
New BEL Road,
Gokula,
Bangalore - 560054 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Lakshmi Priya |
MS Ramaiah Medical College |
Department of Neurosciences,
First Floor, MS Ramaiah Memorial Hospitals, New BEL Road, Gokula, Bangalore
Bangalore
KARNATAKA |
8903211566
lalithapriya.68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramaiah Medical College Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Weekly supplementation of Vitamin D3 60,000 IU single dose |
| Comparator Agent |
Group B |
Daily supplementation of Vitamin D3 at 6000 IU per day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Lab evidence of Vitamin D3 deficiency detected when screened as per guidelines for fibromyalgia or nonspecific musculoskeletal complaints and incidentally detected patients |
|
| ExclusionCriteria |
| Details |
Those on sedatives, granulomatous disorders, volume overload status clinically, pregnant, anaemic, alcohol intake in last 3 months and those who deny to consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sleep quality |
0,8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correction of Vitamin D3 levels by effective method |
0,8 week |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
Final Enrollment numbers achieved (Total)= "87"
Final Enrollment numbers achieved (India)="87" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
31/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [lalithapriya.68@gmail.com].
- For how long will this data be available start date provided 01-05-2024 and end date provided 01-01-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
- This study is designed as a randomised controlled trial where all the adults detected with vitamin D deficiency when screened for the indications based on standard guidelines or incidentally detected will be included and divided into 2 arms where one arm receives a weekly 60000 IU of oral Vitamin D3 for a total of 8 weeks and the other arm receives 6000 IU daily for a period of 8 weeks in addition to advice on adequate lifestyle modifications and dietary changes given for both the groups. Standard questionnaire will be used to record the baseline sleep quality indices (Pittsburg Sleep quality index). After 8 weeks, all the participants will be reassessed with the same standard questionnaire along with a repeat Vitamin D3 estimation. The sleep quality indices shall be compared between baseline and follow up to assess the efficient method of vitamin D3 supplementation in adults detected with Vitamin D deficiency.
|