| CTRI Number |
CTRI/2017/11/010403 [Registered on: 07/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
04/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post-Menopausal Status and Memory Loss |
|
Scientific Title of Study
|
Comparative Assessment of Methylcobalamin and Ascorbic acid on Cognitive Function in Post-Menopausal Women - A Randomized, Double-blind Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayakumar TM |
| Designation |
Assistant Professor |
| Affiliation |
SRM University |
| Address |
Department of Pharmacy Practice,
SRM College of Pharmacy,
SRM University,
SRM Nagar,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
919003400350 |
| Fax |
914427455734 |
| Email |
vijaypractice@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Logaraj M |
| Designation |
Professor and Head |
| Affiliation |
SRM University |
| Address |
Department of Community Medicine,
SRM Medical College Hospital and Research Centre,
SRM University,
SRM Nagar,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
919443185347 |
| Fax |
|
| Email |
mlogaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi KS |
| Designation |
Dean |
| Affiliation |
SRM University |
| Address |
SRM College of Pharmacy,
SRM University,
SRM Nagar,
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
914427453160 |
| Fax |
914427455734 |
| Email |
kslakshmi13@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Pharmacy, SRM University,SRM Nagar, Kattankulathur-603 203, Kancheepuram (Dt), Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
SRM University |
| Address |
SRM Nagar,
Kattankulathur,
Kancheepuram (Dt)
Tamil Nadu |
| 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 |
| Dr KS Pavitra |
SRM Medical College Hospital and Research Centre |
Room No: 21,(URBAN HEALTH TRAINING CENTRE),
Maraimalai Nagar,
Kattankulathur,
Kancheepuram (Dt)
Kancheepuram
TAMIL NADU |
919962938971
kspavitra786@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post Menopausal Women with Impaired Cognitive Function, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ascorbic Acid (Vitamin C) |
500 mg once daily for 12 Weeks (Oral) |
| Intervention |
Methylcobalamin (Vitamin B12) |
500 mcg once daily for 12 Weeks (Oral) |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1. MMSE Score 21-24
2. Menopausal women (taken as complete cessation of menstruation for at least 1 year/12 cycles) who had attained menopause for a period extending over 4 – 10 years at the time of inclusion into the study.
|
|
| ExclusionCriteria |
| Details |
1. MMSE Score 25-30
2. History of recent or current Estrogen or hormonal replacement therapy
3. Known hypertensive, diabetic, renal disease, endocrine disorders, overt nutritional deficiency states, anemia, liver disease or those having history of psychiatric illness.
4. History of Women having estrogen secreting ovarian tumors, for e.g., granulosa and theca cell tumors, tumors of the adrenal gland.
5. Known history of neurological disorders including CVA, space occupying lesions, epilepsy and developmental anomalies.
6. Women, who are physically unable to hear, read or understand written or explained instructions properly, or may have a motor deficit that affects writing and drawing skills.
7. Women, who are already in any of the antioxidant or dietary supplement therapy.
|
|
|
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 |
| Vitamin B12 and Vitamin C Effects on Cognitive Function will be studied |
Baseline, 45 days, 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relation between estrogen and cognitive function will be studied |
Baseline, 45 days, 90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "53"
Final Enrollment numbers achieved (India)="53" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/12/2015 |
| Date of Study Completion (India) |
30/04/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
T.M.Vijayakumar, K.Pavitra, Logaraj M. Comparative assessment of methylcobalamin and ascorbic acid on cognitive function in post-menopausal women - A randomized, double-blind trial. Contemporary Clinical Trials Communications, 2017; 8: 175-180. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study was designed to compare the effect of Methylcobalamin
and ascorbic acid on cognitive function in post-menopausal women. An assessment
of cognitive function was conducted using MMSE tests and serum β-amyloid42
levels. The MMSE is a modified screening tool used to evaluate cognitive
deficits and assessments are simple and can be applied in primary health care
with low cost. No
significant differences were observed between ascorbic acid and methylcobalamin
groups in a number of reported adverse events, and no subjects were removed
from the study for a treatment-related adverse event.
In
Summary, the present study provides evidence that ascorbic acid showed
improvement in cognitive function among post-menopausal women when compared to
methylcobalamin supplement. It is our hope that this preliminary data will be
utilized to design large-scale longer-term trials with similar objectives in post-menopausal
women.
|