| CTRI Number |
CTRI/2022/06/043417 [Registered on: 22/06/2022] Trial Registered Prospectively |
| Last Modified On: |
08/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Assessing the relationship between the dose of vitamin B12 administered and its absorption in the intestine in normal humans |
|
Scientific Title of Study
|
Dose-dependency of vitamin B12 on its intestinal absorption in normal humans |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poorvikha S |
| Designation |
First year MBBS student |
| Affiliation |
St. Johns Medical College |
| Address |
St. Johns Medical College
Marathahalli - Sarjapur Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Phone: 080 4946 6029
Bangalore
KARNATAKA
560034
India |
| Phone |
9731409701 |
| Fax |
|
| Email |
poorvikha.s@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anura V Kurpad |
| Designation |
Professor ,Department of Physiology |
| Affiliation |
St. Johns Medical College |
| Address |
Department of Physiology
St. Johns Medical College
Marathahalli - Sarjapur Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Phone: 080 4946 6029
Bangalore
KARNATAKA
560034
India |
| Phone |
9686512233 |
| Fax |
|
| Email |
a.kurpad@sjri.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Poorvikha S |
| Designation |
First year MBBS student |
| Affiliation |
St. Johns Medical College |
| Address |
St. Johns Medical College
Marathahalli - Sarjapur Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Phone: 080 4946 6029
Bangalore
KARNATAKA
560034
India |
| Phone |
9731409701 |
| Fax |
|
| Email |
poorvikha.s@stjohns.in |
|
|
Source of Monetary or Material Support
|
| Clinical Research Funds St. Johns Medical college (intramural funding) |
|
|
Primary Sponsor
|
| Name |
Clinical Research Centre Department of Physiology |
| Address |
St. Johns Medical college
Sarjapur road, Bangalore-560034 |
| 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 |
| Poorvikha S |
Metabolic Lab, St. Johns Medical College |
Department of Physiology, St. Johns Medical college, Sarjapur Road, Bangalore-560034
Bangalore
KARNATAKA |
08049466349
poorvikha.s@stjohns.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
During screening,Complete Blood Count , plasma total B12 and Holo-TC concentration will be tested in blood and volunteers with clinical deficiency of vitamin B12 will be excluded from the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL/Not Applicable |
NIL/Not Applicable |
| Comparator Agent |
NIL/Not Applicable |
NIL/Not Applicable |
| Intervention |
Stable isotope-labelled vitamin B12 ([13C]-cyanocobalamin ) |
3 doses of [13C]-cyanocobalamin,i.e, 2.5mcg,5mcg and 10mcg , will be given to each participant after dissolving in 2ml distilled water on 3 different days , each followed by a washout period of 10 days . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Apparently healthy participants between the ages of 18 and 40.
2. BMI <25
3. Normal plasma total B12 level
4. Normal active B12 or Holo-TC concentration
|
|
| ExclusionCriteria |
| Details |
1. Participants with existing vitamin B12 deficiency
2. Participants with folate deficiency on clinical supplementation
3. Participants with end-stage renal disease or on haemodialysis, atrophic gastritis, history of alcoholism, use of drugs (methotrexate, antacids, and metformin) known to affect B12 absorption, and on antibiotics/medication known to influence GI motility.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vitamin B12 bioavailability |
7 hours after administration of Vitamin B12 dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in the bioavailability of vitamin B12 with increase in dose administered(2.5 , 5 and 10 mcg) |
7 hours after administration of vitamin B12 dose |
|
|
Target Sample Size
|
Total Sample Size="9"
Sample Size from India="9"
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)
|
15/07/2022 |
| 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="2"
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)?
Response - NO
|
|
Brief Summary
|
This is a randomised crossover study assessing the dose dependency of vitamin B12 on its intestinal absorption in normal individuals. Each participant will receive 3 doses of B12 ,i.e, 2.5, 5 and 10mcg on 3 different days separated by a washout period of 10 days between each dose to ensure the plasma enrichment of B12 reaches pre-dosage level. The primary objective of the study is to determine the absorption of B12 at the three different intake doses . The secondary objective is to investigate the relationship between plasma B12 concentration
at screening and the absorption of B12 at the normal daily intake
dose of 2.5 µg. Post dosing blood samples will be collected at 1st hour followed by hourly collection from 5 to 7 hours. Blood samples will be analysed within 96 hours. Correlation between amount of B12 dose ingested and its bioavailability will be established.
|