FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2012/07/002799 [Registered on: 16/07/2012] Trial Registered Retrospectively
Last Modified On: 01/12/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of vitamin B12 fortified nutrient bar supplementation in Indian children 
Scientific Title of Study   Efficacy of vitamin B12 fortified food supplement in Indian children 
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 
Affiliation  KEM Hospital and Research Centre 
Address  Rasta Peth

Pune
MAHARASHTRA
411011
India 
Phone  020-26111958  
Fax  020-26111958  
Email  diabetes@vsnl.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Chittaranjan Yajnik 
Designation  Director 
Affiliation  KEM Hospital and Research Centre 
Address  Rasta Peth


MAHARASHTRA
411011
India 
Phone  020-26111958  
Fax  020-26111958  
Email  diabetes@vsnl.com  
 
Details of Contact Person
Public Query  
Name  Ms Himangi Lubree 
Designation  Research Officer 
Affiliation  Diabetes Unit, KEM Hospital Research Centre 
Address  Rasta Peth

Pune
MAHARASHTRA
411011
India 
Phone  020-26111958  
Fax  020-26111958  
Email  himangi1971@hotmail.com  
 
Source of Monetary or Material Support  
Diabetes Unit, KEMHRC, Pune and Department of Biotechnology, New Delhi 
 
Primary Sponsor  
Name  Department of Biotechnology, Government of India 
Address  CGO Complex, Lodhi Road, New Delhi, PIN 110003 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Chittaranjan S Yajnik  Diabetes Unit  6th floor, Banoo Coyaji Building, KEM Hospital, Sardar Moodliar Road, Rasta Peth, Pune 411011
Pune
MAHARASHTRA 		 020-26111958
020-26111958
diabetes@vsnl.com 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Improving vitamin status 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Rite Bite Krunch Nutrient Bar (Control):  RiteBite KRUNCH Bar nutrients %RDA (approx values/30g bar) Calories 130 kcal per bar Protein 1.6 g per bar Fat 5.3 g Carbohydrates 19 g Intervention for 120 days 
Intervention  Rite Bite Krunch Nutrient Bar (Fortified with Multiple micronutrients):  RiteBite KRUNCH Bar nutrients %RDA (approx values/30g bar) Calories 130 kcal per bar Protein 1.6 g per bar Fat 5.3 g Carbohydrates 19 g Vitamin A 600 µg Vitamin D 5 µg Vitamin E 11 mg Vitamin C 45 mg Vitamin K 60 µg Iron 10 mg Zinc 8 mg Copper 700 µg Iodine 120 µg Thiamine 0.9 mg Riboflavin 0.9 mg Vitamin B6 1.0 mg Niacin 12 mg Folate 300 µgDFE Vitamin B12 1.8 µg Intervention for 120 days 
Intervention  Rite Bite Krunch Nutrient Bar (Fortified with Vitamin B12):  RiteBite KRUNCH Bar nutrients %RDA (approx values/30g bar) Calories 130 kcal per bar Protein 1.6 g per bar Fat 5.3 g Carbohydrates 19 g Intervention for 120 days 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  • Age between 10-13yrs
• Willing to consent /assent and participate in the study
 
 
ExclusionCriteria 
Details  • Plasma B12 concentration < 100 pmol/L
• Hemoglobin < 10 g/ dL
• Already taking supplements containing vitamin B12 for 10 or more days
• On treatment with drugs known to impair the absorption or utilization of B12 (for example, phenytoin, antacids)
• Medical conditions interfering with B12 absorption and utilization; chronic gastro-intestinal disease and worm infestations
• Chronic illnesses preventing participation 
 
Method of Generating Random Sequence   Stratified 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  120 days (baseline and post-intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2011 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A; will be published as an originalpaper after completion 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

This will be a double-blind, randomized, placebo-controlled trial having 3 groups (nutrient bar, nutrient bar fortified with vit B12, nutrient bar fortified with multiple micronutrients including vit B12). Each group will have 50 children (age 10-13y). 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 EC, KEM Hospital Research Centre, Pune.

Data (height, weight and venous blood sample) will be collected at baseline and after 5 months.

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 vitamin B12 (crystalline) supplementation in capsule form (Deshmukh US et al). If vitamin B12 in 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.

Progress of study
 We screened 172 volunteers, they were briefed about the study and their consent sought. One hundred forty three consented to take part in the study. The subjects were screened for inclusion and exclusion criteria. Twenty three volunteers were excluded due to low vitamin B12 concentrations (<100 pM/L) and 2 were excluded due to low haemoglobin concentrations (<7 mg%). One hundred and eighteen were randomised into three groups. The intervention started on 23rd December and was completed on 20th May 2014.

Conclusions:

Crystalline B12 fortified yogurt improved B12 status while Propionibacetria fortified did not. Yogurt may used as a vehicle for B12 supplementation in B12 deficient vegetarian populations and could be considered a component of midday school programmes. 


 
Close