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.)
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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.
排除标准
- •Lactating Women 2) 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.
- •Participated in any clinical trial within last 30 days at the time of screening.
- •Any disorder or condition that in the opinion of investigator would prohibit study participation or affect study outcome.
结局指标
主要结局
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)
时间窗: 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)
次要结局
- 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))