| CTRI Number |
CTRI/2017/01/007712 [Registered on: 16/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/01/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Only healthy volunteers |
| Study Design |
Randomized, Crossover 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
|
Uptake of various forms and amounts of vitamin B12 (Part I-IMPROVIT) |
| Trial Acronym |
IMPROVIT |
|
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 |
Pathology Department, Deenanath Mangeshkar Hospital and Research Center |
| Address |
Pathology Department, Deenanath Mangeshkar Hospital and Research Center, Erandwane, Pune
Pathology Department, Deenanath Mangeshkar Hospital and Research Center, Erandwane, 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 |
Pathology Department, Deenanath Mangeshkar Hospital and Research Center |
| Address |
Pathology Department, Deenanath Mangeshkar Hospital and Research Center, Erandwane, Pune
Pathology Department, Deenanath Mangeshkar Hospital and Research Center, Erandwane, 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 |
Pathology Department, Deenanath Mangeshkar Hospital and Research Center |
| Address |
Pathology Department, Deenanath Mangeshkar Hospital and Research Center, Erandwane, Pune
Pathology Department, Deenanath Mangeshkar Hospital and Research Center, Erandwane, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
|
| Fax |
|
| Email |
sadu_naik@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology New Delhi India |
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology New Delhi India |
| Address |
Block-2,6th Floor, CGO Complex, Lodhi Road, New Delhi |
| 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 |
Erandwane, Pune
Pune
MAHARASHTRA |
49153194
sadu_naik@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Danish Ethical Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vegetarian with vith vitamin B12 deficiency (Pl. B12 less than 148 pmol/L) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydroxo cobalamin and cyano cobalamin in vitamin B12 sufficient (more than 148 pmol/L) 3, 6 and 9 microgram |
Day 0: oral intake of 3/6/9 microgram three times a day; Day1: 3/6/9 microgram thrice a day
Blood collection on day 0 and day 3 |
| Comparator Agent |
hydroxocobalamin and cyanocobalmin in vitamin B12 deficient participants (less tha 148 pmol/L) |
oral three doses of hydroxocobalamin and cyanocobalmin (both 1.5, 3.0 and 6.0 ug three times a day for 2 days)and study the effects on circulating holotrancobalaminin vitamin B12 deficient participants |
|
|
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 and with normal vitamin B12 status Danish 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 |
| Difference in uptake |
Baseline and two days after supplementation and then crossover |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Metabolic effects of both cyano and hydroxo coabalamin in vegetarian Indians |
Holotranscoabalamin levels before and after supplementation and crossover |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2015 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Results are being analysed |
|
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 2-3 folds higher in cyanocobalamin supplemented than hydroxocobalamin supplemented participants. Detail analysis is being carried out . |