| CTRI Number |
CTRI/2020/10/028370 [Registered on: 13/10/2020] Trial Registered Prospectively |
| Last Modified On: |
06/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to evaluate the effect of Methylcobalamine nasal spray in patients with subclinical cobalamin deficiency. |
|
Scientific Title of Study
|
A prospective, randomized, open label, clinical study to evaluate safety and effectiveness of novel methylcobalamin nasal spray compared to oral methylcobalamin in the treatment of subjects with SubClinical Cobalamin (Vitamin B12) Deficiency (S.C.C.D.) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhir Kumar |
| Designation |
Consultant Neurologist |
| Affiliation |
Apollo Hospitals |
| Address |
Department of Neurology, Room No. 955, International wing, Apollo Hospitals, Jubilee Hills, Hyderabad, Telangana-500033
Hyderabad
TELANGANA
500033
India |
| Phone |
9866193953 |
| Fax |
|
| Email |
drsudhirkumar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Kumar |
| Designation |
Consultant Neurologist |
| Affiliation |
Apollo Hospitals |
| Address |
Department of Neurology, Room No. 955, International wing, Apollo Hospitals, Jubilee Hills, Hyderabad, Telangana-500033
Hyderabad
TELANGANA
500033
India |
| Phone |
9866193953 |
| Fax |
|
| Email |
drsudhirkumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhir Kumar |
| Designation |
Consultant Neurologist |
| Affiliation |
Apollo Hospitals |
| Address |
Department of Neurology, Room No. 955, International wing, Apollo Hospitals, Jubilee Hills, Hyderabad, Telangana-500033
Hyderabad
TELANGANA
500033
India |
| Phone |
9866193953 |
| Fax |
|
| Email |
drsudhirkumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sudhir Kumar, Apollo Hospitals, Jubilee Hills, Hyderabad, Telangana-500033 |
|
|
Primary Sponsor
|
| Name |
Dr Sudhir Kumar |
| Address |
Department of Neurology, Room No. 955, International wing, Apollo Hospitals, Jubilee Hills, Hyderabad, Telangana-500033 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudhir Kumar |
Apollo Hospitals |
Department of Neurology, Room No:955, International wing,Jubilee Hills, Hyderabad, Telangana-500033
Hyderabad
TELANGANA |
9866193953
040-29882138
drsudhirkumar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Clinical Studies |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D618||Other specified aplastic anemias and other bone marrow failure syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Methylcobalamin (250 µg/Spray) nasal spray |
This study will have simple random sampling procedure to randomize the subjects to Group-A and B. Based on randomization procedure, Group-A will be assigned to the dose of two novel methylcobalamin nasal spray twice a week and Group-B will be assigned to the dose of 1500 mcg single daily dose till the study period of 30 days. |
| Intervention |
Methylcobalamin 1500 microgram oral tablet |
This study will have simple random sampling procedure to randomize the subjects to Group-A and B. Based on randomization procedure, Group-A will be assigned to the dose of two novel methylcobalamin nasal spray twice a week and Group-B will be assigned to the dose of 1500 mcg single daily dose till the study period of 30 days. |
|
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Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Vitamin B12 level [200 pg/mL – 399pg/mL ( 148pmol/L – 295pmol/L)]
2) Above the age of 18 years
3) Willing & able to comply with study requirements, e.g. usage of medicines as per protocol, willing to adhere with study visit schedule and willing to fill Patient Diary, as indicated by written informed consent provided by the patient.
4) Study population will be EITHER any of the following in either gender:
a) General Population
b) Patients who are on Metformin (≥1000mg/day) therapy for ≥ 4 months
c) Anaemic patients having hemoglobin level of < 9g/dL
d) Chronic Alcoholic Patients as per DSM V criteria
e) Patients on PPI therapy for ≥ 6 months
f) Patients who have undergone Bariatric Surgery (e.g. RYGB surgery/ Mini gastric bypass surgery/ Sleeve Gastrectomy/ Sleeve Gastroplasty etc) OR Gastric Surgery for any indication.
OR Study population will be any of the following in female population:
g) Women on Oral Contraceptive Pills
h) Women with Poly Cystic Ovarian Disease(PCOD) on Metformin
5) If women of childbearing potential are recruited they must be non-pregnant (supported by negative urine pregnancy test at screening), and be willing to maintain reliable birth control throughout the study.
|
|
| ExclusionCriteria |
| Details |
1) Lactating Women
2) Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication.
3) Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections.
4) Patient using any other nasal medication/device.
5) Patients having a known diagnosis of severe renal impairment or renal failure. Patients on treatment with drugs which interfere with vitamin B12 assay.
6) Participated in any clinical trial within last 30 days at the time of screening.
7) Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and efficacy of Vitamin B12 in comparison of changes in Vitamin B12 levels post 30 days(i.e, 08 doses for Group-A and 30 doses for Group-B) |
To evaluate the safety and efficacy of Vitamin B12 in comparison of changes in Vitamin B12 levels post 30 days(i.e, 08 doses for Group-A and 30 doses for Group-B) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Proportion of subjects achieving Vitamin B12 levels (300 pg/ml) on day 31 (Group-B) and (Group-A)
2) Proportion of subjects achieving Vitamin B12 levels (200-399 pg/ml) on day 31 (Group-B) and (Group-A) |
end of the study |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
19/10/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an investigator initiated study to evaluate the safety and efficacy of novel methylcobalamin nasal spray compared to oral methylcobalamin in the treatment of subjects with Subclinical Cobalamin (Vitamin B12) Deficiency (S.C.C.D) that are already approved and marketed in India for so long. However, the current study is planned to evaluate the novel methylcobalamin nasal spray compared to oral methylcobalamin in Vitamin B12 deficiency patients.
The drugs that will be used in this study are as follows: (Methylcobalamin 250 microgram nasal spray and methylcobalamin 1500 microgram oral tablet)
This study is planned to be conducted in Apollo Hospitals, Jubilee Hills, Hyderabad with a sample size 100. |