| CTRI Number |
CTRI/2021/06/034312 [Registered on: 18/06/2021] Trial Registered Prospectively |
| Last Modified On: |
17/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To study the gender-wise difference in
Vit B12 and Vit D deficiency, Gender wise categorization of clinical symptoms and reversal of symptoms with appropriate supplementation with vitamin B12 or vitamin D pills |
|
Scientific Title of Study
|
  Vitamin B12 and Vitamin D deficiency gender-wise categorization of clinical symptoms and reversal of symptoms with appropriate supplementation-A RCT. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sadanand S Naik |
| Designation |
Senior Consultant Biochemsit |
| Affiliation |
Deenanath Mangeshkar Hospital and Res centre Pune |
| Address |
Clinical Biochemistry Department First Floor Deenanath Mangeshkar Hospital and Research Center Erandwane Pune 411004 India Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
02049153178 |
| Fax |
|
| Email |
dr.sadanandnaik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadanand S Naik |
| Designation |
Senior Consultant Biochemsit |
| Affiliation |
Deenanath Mangeshkar Hospital and Res centre Pune |
| Address |
Clinical Biochemistry Department First Floor Deenanath Mangeshkar Hospital and Research Center Erandwane Pune 411004 India Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
02049153178 |
| Fax |
|
| Email |
dr.sadanandnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadanand S Naik |
| Designation |
Senior Consultant Biochemsit |
| Affiliation |
Deenanath Mangeshkar Hospital and Res centre Pune |
| Address |
Clinical Biochemistry Department First Floor Deenanath Mangeshkar Hospital and Research Center Erandwane Pune 411004 India Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
02049153178 |
| Fax |
|
| Email |
dr.sadanandnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deenanath Mangeshkar Hospital and Research Center, Pune |
|
|
Primary Sponsor
|
| Name |
Deenanath Mangeshkar Hospital and Research Center Pune |
| Address |
Erandawane Pune 411004 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Namita Mahalle |
Clinical Biochemistry (Pathology) and Orthopaedics Department |
First Floor Deenanath Mangeshkar Hospital and Research Center Erandawane Pune 411004
Pune
MAHARASHTRA |
9689935996
pnmahalle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vitamin B12 and Vitamin D Normal and deficient subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High dose of Vitamin B12 and Vitamin D |
One tablet each of Vitamin B12 and Vitamin D per day for four weeks |
| Intervention |
Nil |
Nil |
| Intervention |
Vitamin B12 |
One tablet of Vitamin B12 per day for four weeks |
| Comparator Agent |
Vitamin B12 and Vitamin D |
One tablet of Vitamin B12 and Vitamin D per day for four weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Normal plasma Vitamin B12 and Vitamin D levels
2. Plasma Vitamin B12<250 pg/ml and vitamin D > 30 ng/dL
3. Plasma Vitamin B12<250 pg/ml and vitamin D < 30 ng/dL |
|
| ExclusionCriteria |
| Details |
1.Subjects taking B12 supplementation
2. Subjects on medication which interferes with B12 absorption and metabolism (e.g. methorexate, anta cids, metformin)
3. Subjects with diabetes, cancer, pregnancy., known chronic systemic diseases.
4. Age-below18 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gender wise differentiation of clinical symptoms and post supplementation reversal of vitamin B12 and Vitamin D deficiency |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of vitamin B12 and D status with supplementation |
6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/06/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil at present |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We have designed a study
with the objective to 1. assess association of
symptoms with different levels of B12 deficiency and also gender wise
categorization of the symptoms 2. to see the effect of combined
treatment of B12 and Vit D on VitaminB12, VitaminD, Holotranscobalamin and
homocysteine in Vitamin B12 deficient subjects.
|