| CTRI Number |
CTRI/2017/06/008811 [Registered on: 12/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/05/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Only healthy volunteers |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Identification of a suitable milk-derived product, the consumption of which could prevent vitamin B12 deficiency (IMPROVIT) |
|
Scientific Title of Study
|
Long term uptake study of 3 ug of Hydroxo Vitamin B12 and Cyano Vitamin B12 in Indians adults (IMPROVIT- PART II) |
| 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 |
Consultant Biochemist |
| Affiliation |
Deenanath Mangeshkar Hospital, Pune, Maharashtra, India |
| Address |
Pathology Laboratory
Deenanath Mangeshkar Hospital and Research Center, Erandawane, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
sadu_naik@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadanand S Naik |
| Designation |
Consultant Biochemist |
| Affiliation |
Deenanath Mangeshkar Hospital, Pune, Maharashtra, India |
| Address |
Pathology Laboratory
Deenanath Mangeshkar Hospital and Research Center, Erandawane, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
sadu_naik@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadanand S Naik |
| Designation |
Consultant Biochemist |
| Affiliation |
Deenanath Mangeshkar Hospital, Pune, Maharashtra, India |
| Address |
Pathology Laboratory
Deenanath Mangeshkar Hospital and Research Center, Erandawane, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
sadu_naik@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology
International Collaboration
Ministry of Science & Technology
Govt of India,
Block 2, CGO complex
New Delhi 110003
|
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology New Delhi India |
| Address |
Department of Biotechnology International Collaboration Ministry of Science & Technology Govt of India, Block 2, CGO complex New Delhi 110003 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| DrSadanand S Naik |
Deenanath Mangeshkar Hospital and Research Center |
Pathology Department, Deenanath Mangeshkar Hospital and Research Center, Erandawane, Pune
Pune
MAHARASHTRA |
8805375594
sadu_naik@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Deenanath Mangeshkar Hopsital and Res Centre, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age: More than 18 years |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Vegetarians with low plasma vitamin B12 in Indian participants |
|
| ExclusionCriteria |
| Details |
Non vegetarians, cancer and the participants consuming vitamin B12 pills and the drugs known to influence vitamin B12 absorption |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in homocysteine due to hydroxocobalamin intake |
Baseline and every week till eight weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Better uptake due to hydroxocobalamin, Increase in holoTC and reduction in Homocysteine |
Baseline and every week till eight weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2016 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None as yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The rise in plasma holotranscobalamin is significantly higher and reduction in homocysteine is lower in hydroxocobalamin administered participants than those of cyanocobalamin administered. |