| CTRI Number |
CTRI/2024/12/078143 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study on Vitamin B12 supplementation in adults. |
|
Scientific Title of Study
|
A double-blind, placebo-controlled clinical trial to evaluate the effect Vitamin B12 supplementation in adults with marginal Vitamin B12 Deficiency |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/046 Ver. 1.00 Dated 12/11/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramshyam Agarwal |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Fourth floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
8087282022 |
| Fax |
- |
| Email |
ramshyam.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishnavi Patil |
| Designation |
Project Coordinator |
| Affiliation |
Life Synergy |
| Address |
Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan
nagar, Baner
Pune
MAHARASHTRA
411045
India |
| Phone |
9834585994 |
| Fax |
- |
| Email |
vaishnavilifesynergy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnavi Patil |
| Designation |
Project Coordinator |
| Affiliation |
Life Synergy |
| Address |
Office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan
nagar, Baner
MAHARASHTRA
411045
India |
| Phone |
9834585994 |
| Fax |
- |
| Email |
vaishnavilifesynergy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Life Synergy office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan nagar, Baner,
Pune 411045, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Life Synergy |
| Address |
office no 503, Orbisoul 46 Downtown, Pashan-Sus road, Mohan
nagar, Baner, Pune 411045, Maharashtra |
| Type of Sponsor |
Other [Nutraceutical product promoter] |
|
|
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 |
| Dr Ramshyam Agarwal |
Lokmanya Medical Research Centre and Hospital |
Fourth floor OPD 401
314 B Telco Road
Chinchwad
Pune
MAHARASHTRA |
8087282022
-
ramshyam.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Lokmanya Medical Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LS/24-25/Vit001 |
One capsule twice a day after main meal for 90 days. |
| Comparator Agent |
Placebo |
One capsule twice a day after main meal for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Men and women aged 18 years or older who follow a vegetarian, vegan diet 2. Present serum vitamin B12 levels of 148 to 221 pmol per L [201 to 300 pg per mL]) and with or without symptoms associated with vitamin B12 deficiency 3. Sign the informed consent. |
|
| ExclusionCriteria |
| Details |
1. Present diagnosed diseases that may interfere with vitamin B12 markers, including gastrointestinal diseases (such as inflammatory bowel disease, celiac disease, ileal resection, Crohns disease, constipation or atrophic gastritis), pancreatic diseases, kidney diseases, liver diseases, diabetes, cardiovascular diseases, pernicious anemia and cancer
2. Medical history of abdominal surgery that may influence the absorption of vitamin B12 (such as bariatric surgery)
3. Being on hemodialysis treatment
4. Present values of body mass index less than or equal to 18.5 kg per meter square or greater than or equal to 35 kg per meter square
5. Having consumed or consuming vitamin B12 or folate supplements for more than 2 months before inclusion in the study
6. Have taken medications that affect the absorption and therapeutic response of vitamin B12 (such as methotrexate, metformin, proton pump inhibitors, H2 receptor antagonists, histamine, nitrous oxide, colchicine, neomycin, biguanides, cholestyramine, aminosalicylic acid, chloramphenicol and other bone marrow depressants) one month before inclusion in the study
7. Participants with known systemic and metabolic diseases in the investigators discretion not proving fit for trial
8. Known hypersensitivity to investigational products
9. Participants currently taking any of the following supplements for health maintenance or benefits: multivitamin mineral (MVM), B vitamins, fish oil, Ayurvedic or herbal supplements, nutraceutical supplements, fiber supplements, glucosamine or chondroitin probiotics, iron supplements, or protein powders
10. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
11. Any prescribed medication except for oral contraceptives (not acceptable if oral contraceptives are used to disrupt normal or monthly menstrual cycle) includes recent antibiotic and or oral corticosteroid use
12. Donated blood within two months before study entry, and must not donate blood during the study duration
13. Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude the successful completion of the study
14. Have participated in any investigational therapeutic trial within the past 1 year that the investigator feels would influence or affect the outcome of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in vitamin B12 levels
2. Changes in State-Trait Anxiety Inventory score
3. Changes in Fatigue severity scale score
4. Assessment of energy audit diary
5. Changes in Health Organization Quality of Life (WHOQOL BREF) questionnaire score |
1. Screening, day 30, day 60 and day 90
2. Screening, day 30, day 60 and day 90
3. Screening, day 30, day 60 and day 90
4. Day 1, day 30, day 60 and day 90
5. Screening and day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Adverse events profile
2. Compliance and tolerability of the investigational product |
1. Baseline, day 30, day 60 and day 90
2. Screening, day 30, day 60 and day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/12/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vitamin B12 supplementation in adults with marginal deficiency can improve various physiological and neurological outcomes. Marginal B12 deficiency, often caused by dietary inadequacies or malabsorption, may lead to symptoms like fatigue, mild cognitive impairment, and mood disturbances. Studies suggest that supplementation (via oral or intramuscular routes) effectively increases serum B12 levels and improves related biomarkers, such as homocysteine and methylmalonic acid, which are associated with cardiovascular and neurological health. Additionally, supplementation may alleviate symptoms like low energy and memory issues, though the extent of benefit varies. Early intervention is key to preventing progression to more severe deficiencies and irreversible complications. |