| CTRI Number |
CTRI/2020/01/023087 [Registered on: 31/01/2020] Trial Registered Prospectively |
| Last Modified On: |
30/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To identify the benefits of supplementation of vitamin D under supervision as compared to self administration among vitamin D deficient staff working in anesthesia department |
|
Scientific Title of Study
|
A prospective, randomized controlled clinical trial to assess the efficacy of directly observed vitamin D supplementation among vitamin D deficient anesthesia workers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reshma Mariam Biju |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department of Anesthesia
Christian Medical College
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
8270704709 |
| Fax |
|
| Email |
reshandjeff@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anita Shirley |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anesthesia
Christian Medical College
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
917358377164 |
| Fax |
|
| Email |
anjeyanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reshma Mariam Biju |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department of Anesthesia
Christian Medical College
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
8270704709 |
| Fax |
|
| Email |
reshandjeff@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ethical committee
Institutional review board
Christian medical college, Vellore |
|
|
Primary Sponsor
|
| Name |
fluid research fund |
| Address |
Office of Research
Institutional Review Board
christian Medical College Vellore |
| Type of Sponsor |
Research institution |
|
|
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 Reshma Mariam Biju |
Christian Medical College |
Office of Department of Anesthesia
Main hospital block basement
CMCH,Vellore, 632004
Tamilnadu
Vellore
TAMIL NADU |
8270704709
reshandjeff@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| office of research, institutional review board, christian medical college , vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anaesthesia staff technicians with serum vitamin D level less than 30ng/ dl |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Directly observed supplementation |
This group that is deficient in vitamin D will be supplemented under direct supervision with 60000 IU vitamin D3 liquid preparation per oral once in every week for 8 weeks and once in every 4 weeks for next 24 weeks |
| Comparator Agent |
Self administered group |
This group that is deficient in vitamin D will have to take 60000 IU of vitamin D3 liquid preparation, once every week for 8 weeks and once in every r weeks for next 24 weeks, own their own |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
healthy volunteers with 25(OH)D levels < 30 ng/ml |
|
| ExclusionCriteria |
| Details |
age less than 18 years
subjects with chronic illness and other endocrine disorders
subjects who are on vitamin D supplementation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparing the difference in the improvement of serum vitamin D level at the end of eight months of supplementation of 25(OH)d to both groups |
comparing the difference in the improvement of serum vitamin D level at the end of eight months of supplementation of 25(OH)d to both groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
improvement in symptoms of vitamin D
improvement in health related quality of life
assess the compliance in both group |
8 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2020 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an interventional study among the healthcare workers in the department of anaesthesia ,CMCH, Vellore, who are found to have deficiency in serum vitamin D levels. The staff workers who are found to have vitamin D levels below the recommended normal values are recruited for the study. A semi-structured questionnaire will be administered to assess the symptoms of vitamin D deficiency, type of work they are involved in, duration of sun exposure, compliance to vitamin D supplementations. The study population is then randomized to two groups observed and unobserved. Participants in the observed group are supplemented under direct observation while the subjects in the unobserved group are asked to take on their own as per the prescribed schedule and to bring back the empty sachets at the end of study. The difference in increase of serum vitamin D levels in both groups are tested, along with assess the improvement in symptoms, compliance and quality of life |