| CTRI Number |
CTRI/2015/04/005703 [Registered on: 17/04/2015] Trial Registered Retrospectively |
| Last Modified On: |
17/10/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of special yoghurt to improve vitamin B12 status. |
|
Scientific Title of Study
|
Improving vitamin B12 status through vitamin B12 producing probiotic fortified yoghurt |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Chittaranjan Yajnik |
| Designation |
Director, Diabetes Unit |
| Affiliation |
KEM Hospital Research Centre |
| Address |
Sardar Moodliyar Road
Rasta Peth
Pune
India
Pune
MAHARASHTRA
411011
India |
| Phone |
020-26111958 |
| Fax |
020-26111958 |
| Email |
diabetes@kemdiabetes.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Chittaranjan Yajnik |
| Designation |
Director, Diabetes Unit |
| Affiliation |
KEM Hospital Research Centre |
| Address |
Sardar Moodliyar Road
Rasta Peth
Pune
India
Pune
MAHARASHTRA
411011
India |
| Phone |
020-26111958 |
| Fax |
020-26111958 |
| Email |
diabetes@kemdiabetes.org |
|
Details of Contact Person
Public Query
|
| Name |
Ms Himangi Lubree |
| Designation |
Research Officer |
| Affiliation |
Diabetes unit, KEM Hospital Research Centre |
| Address |
Sardar Moodliyar Road
Rasta Peth
Pune
MAHARASHTRA
411011
India |
| Phone |
020-26111958 |
| Fax |
020-26111958 |
| Email |
h.lubree@kemdiabetes.org |
|
|
Source of Monetary or Material Support
|
| Diabetes Unit, KEMHRC,Pune and Department of Biotechnology, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology New Delhi |
| Address |
CGO Complex, Lodhi Road, New Delhi, PIN 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 |
| Prof CS Yajnik |
Diabetes Unit |
6th Floor, Banoo Coyaji building, KEM Hospital, sardar moodliyar road, Rasta Peth
Pune
MAHARASHTRA |
02026111958
diabetes@kemdiabetes.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KEM Hospital Research Centre Ethics Committee, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Improving plasma vitamin status |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Yoghurt (Control) |
100 ml yoghurt, White color semisolid with characteristic odour (approx. values/100g yoghurt)Calories 136 kcal, Proteins 5.6g,Fat 6.5g, Carbohydrates 15g
intervention for 120 days |
| Intervention |
Yoghurt (fortified with propionibacterium) |
100 ml yoghurt, White color semisolid with characteristic odour with 1x10 to power 8 of propionibacterium/ 1 g of yoghurt, (approx. values/100g yoghurt)Calories 142 kcal, Proteins 5.6g,Fat 6.5g, Carbohydrates 16g Intervention for 120 days |
| Intervention |
Yoghurt (fortified with vitamin B12) |
100 ml yoghurt, White color semisolid with characteristic odour (approx. values/100g yoghurt)Calories 134 kcal, Proteins 5.2g,Fat 6.0g, Carbohydrates 15g, vitamin B12 2 mcg
Intervention for 120 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
-Age between 18-50yrs
-Willing to consent and participate in the study |
|
| ExclusionCriteria |
| Details |
-Known allergy of milk and milk products
-Severely B12 deficient (less than 100 pmol/L)
-Anemia (Hemoglobin less than 7 g/ 100 ml)
-Pregnant or lactating or planning for pregnancy in the study period
-Already taking supplements containing vitamin B12 for 15 or more days
-On treatment with drugs known to impair the absorption or utilization of B12 (eg phenytoin, antacids, metformin)
-Medical conditions interfering with B12 absorption and utilization; chronic gastro-intestinal disease
-Chronic illnesses preventing participation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| plasma vitamin B12 concentrations |
baseline and 120 days post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/10/2013 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A, will be published as an original paper after completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a double-blind, randomized, placebo-controlled trial having 3 groups (plain yoghurt, B12 fortified yoghurt, B12 producing probiotic fortified yoghurt). Each group will have ~40 adult volunteers (18-50y). The period of supplementation will be 5 months.
This sample size is sufficient to measure vitamin B12 rise of 100 pmol/L (SD 80) above the baseline, with power of 80% and 5% level of significance; and accounts for 5 drop outs per group. Appropriate ethical approval has been obtained from the KEM Hospital Research Centre Ethics Comm ittee, Pune.
Data including Height, Weight, and venous blood sample will be collected at baseline and 5 months post intervention.
Data analysis: We will compare biochemical parameters (hemoglobin, red cell indices, plasma vitamin B12) in the different groups.
The sample size, dose and duration of the trial is based on our previous experience of community based, double blind trial of viamin B12 (crystalline) supplementation in capsule form (Deshmukh US et al). If fortified food form improves the circulating vitamin B12 status, it would provide a convincing mode for tackling widespread vitamin B12 insufficiency in our population
Reference: Deshmukh US, Joglekar CV, Lubree HG, Ramdas LV, Bhat DS, Naik SS, Hardikar PS, Raut DA, Konde TB, Wills AK, Jackson AA, Refsum H, Nanivadekar AS, Fall CH, Yajnik CS. Effect of physiological doses of oral vitamin B12 on plasma homocysteine: a randomized, placebo-controlled, double-blind trial in India. Eur J Clin Nutr. 2010;64:495-502.
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