CTRI/2020/10/028370CompletedPhase 4
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.)
Dr Sudhir Kumar0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Pms
Eligibility Criteria
Inclusion Criteria
- •1) Vitamin B12 level [200 pg/mL ââ?¬â?? 399pg/mL ( 148pmol/L ââ?¬â?? 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 (ââ?°Â¥1000mg/day) therapy for ââ?°Â¥ 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 ââ?°Â¥ 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.
Exclusion Criteria
- •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.
Investigators
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