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clinical study to check safety and effectiveness of novel methylcobalamin nasal spray versus oral methylcobalamin in the treatment of subjects with vitamin B12 deficiency

Investigational Products Methylcobalamin (250mcg/spray) nasal spray and Methylcobalamin 1500 mcg oral tablet .Indication Treatment for Vitamin B12 deficiency in consenting adult subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/028143
Enrollment
100
Registered
2020-09-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E539- Vitamin B deficiency, unspecified

Interventions

Intervention1: Methylcobalamin Nasal Spray: Each spray will deliver 0.05 ml of solution containing 250 µg of methylcobalamin A dose of two nasal-sprays (one spray in each nostril, a total of 500 mcg

Sponsors

Asian Institute of Gatroentrology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Vitamin B12 level General Population Patients who are on Metformin (>=1000mg/day) therapy for >= 4 months Anaemic patients having hemoglobin level of Chronic Alcoholic Patients as per DSM V criteria Patients on PPI therapy for >= 6 months 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: Women on Oral Contraceptive Pills Women with Poly Cystic Ovarian Disease(PCOD) on Metformin

Exclusion criteria

Exclusion criteria: Lactating Women Patients with known hypersensitivity or allergies to cobalt and/or vitamin B12 or any component of the study medication. Patients with any significant nasal pathology, or having chronic nasal symptoms or nasal allergies or upper respiratory tract infections. Patient using any other nasal medication/device. Patients having a known diagnosis of severe renal impairment or renal failure. Patients on treatment with drugs which interfere with vitamin B12 assay

Design outcomes

Primary

MeasureTime frame
Comparison of change in Vitamin B12 levels on day 7 [i.e. after 03 doses of Nasal B12(Group -A) or 06 doses of oral B12(Group-B) ]Timepoint: Day 7—

Secondary

MeasureTime frame
Comparison in change in Vitamin B12 levels on day 7 for Group-B and day 14 for Group-A Comparison in change in Vitamin B12 levels on day 14 for Group-A and Group-B Proportion of subjects achieving Vitamin B12 levels â?¥ 200 pg/mL on day 7 (Group-B) and on day 14 (Group-A) Proportion of subjects achieving Vitamin B12 levels â?¥ 400 pg/mL on day 7 (Group-B) and on day 14 (Group-A) Proportion of subjects achieving Vitamin B12 levels â?¥ 200pg/mL on day 14 for both the treatment groups Timepoint: Day 7 and Day 14—

Countries

India

Contacts

Public ContactDr Manu Tandon

Asian Institute of Gastroentrology

mantan_05@rediffmail.com04023378888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026