| CTRI Number |
CTRI/2025/12/098784 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Compare the effects of vitamin B9, B12, C, D on Cognitive Function in patients with Parkinson's disease |
|
Scientific Title of Study
|
Comparative Efficacy of Selected Vitamins (B9, B12, C, and D) on Cognitive Function in Parkinsons Disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Safreen Rumana |
| Designation |
Student |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu district, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9488356526 |
| Fax |
|
| Email |
ss8379@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M G Rajanandh |
| Designation |
Professor |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu district, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598464723 |
| Fax |
|
| Email |
mgr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Robert wilson |
| Designation |
Professor |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Department of Neurology, SRM Medical College Hospital & Research Centre, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu district, Tamil Nadu, India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9952040784 |
| Fax |
|
| Email |
robertws@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College and Research Centre, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu district- 603203, Tamil nadu, India |
|
|
Primary Sponsor
|
| Name |
SRM Medical College and Research centre |
| Address |
SRM Institute of Science and Technology, Kattankulathur, Chengalpattu district- 603203, Tamil nadu, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S Robert Wilson |
SRM Medical College Hospital and Research Centre, Kattankulathur - 603203 |
Department of Neurology, SRM Institute of Science and Technology, Kattankulathur- 603203
Kancheepuram
TAMIL NADU |
9952040784
robertws@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRM Medical College,Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care |
Standard Care (Carbidopa 25mg + Levodopa 100mg) thrice daily oral for 6 months |
| Intervention |
Standard Care + Vitamin B12 |
Standard Care (Carbidopa 25mg + Levodopa 100mg) thrice daily oral + Vitamin B12 2.4mcg once daily oral for 6 months |
| Intervention |
Standard Care + Vitamin B9 |
Standard Care (Carbidopa 25mg + Levodopa 100mg) thrice daily oral + Vitamin B9 400mcg once daily oral for 6 months
|
| Intervention |
Standard Care + Vitamin C |
Standard Care (Carbidopa 25mg + Levodopa 100mg) thrice daily oral + Vitamin C 90mg once daily oral for 6 months |
| Intervention |
Standard Care + Vitamin D |
Standard Care (Carbidopa 25mg + Levodopa 100mg) thrice daily oral + Vitamin D 15mcg once daily oral for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Cognitive impairment (MoCA score below 24)receving standard PD therapy |
|
| ExclusionCriteria |
| Details |
Patients with Thalassemia
Individual diagnosed with G6PD deficiency or Sickle cell disease
Subject with Hemochromatosis (serum ferritin more than 1000ng/ml & transferrin saturation more than 45 percent
Participants presenting with severe kidney disease or advanced renal/liver impairment (eGFR less than 30 ml/min/1.73m^2 , child pugh class C)
History of gastric ulcers or pernicious anemia (vit B12 less than 150pg/ml)
Case of severe anemia (HB less than 7g/dl)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of this study will give a clear understanding of the cognitive enhancing abilities of vitamins (B9,B12,C&D) among Indian population |
Biomarker assessment: Beta amyloid 40 & 42 ratio
Baseline , 3rd month, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety & tolerability of these vitamins by monitoring ADRs
To compare the quality of life between control & treatment groups using scores & scales |
MoCA & Neuro QoL score scale assessment: Baseline, 3rd month & 6th month
|
|
|
Target Sample Size
|
Total Sample Size="155"
Sample Size from India="155"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/12/2025 |
| 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="6"
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
|
Patients with Parkinsons disease are screened for eligibility based on diagnosis cognitive status MoCA less than 24 and medical exclusions including G6PD deficiency thalassemia liver or kidney disease ulcers and anemia Eligible participants provide informed consent and are assigned into five separate groups Group one receives standard care only Group two receives standard care with vitamin B9 Group three receives standard care with vitamin B12 Group four receives standard care with vitamin C Group five receives standard care with vitamin D Baseline assessments include demographics vitals clinical history laboratory test such as Beta amyloid 40 and 42 ratio biomarker levels MoCA and Neuro QoL score scale Participants are monitored for adherence side effects and use of any additional medicines during the study Follow up evaluations at baseline month three and month six include amyloid biomarker ratio cognitive function MoCA quality of life Neuro QoL and recording of adverse events After six months a final analysis is done to assess efficacy safety and improvement in quality of life |