A Prospective, Open Label, Triple-Arm, Randomized, Comparative, Placebo, Active Controlled Bioavailability Study of 25-hydroxyvitamin D2 enriched Shiitake Mushroom in 25-hydroxyvitamin D deficient (Serum levels =50 nmol/l), otherwise healthy, adult, human subjects under fasting condition.

CSIR Institute of Himalayan Bioresource Technology0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年1月22日

试验速览

暂无简介。

•1.Male/Female patients aged between 21-45 years (Both Inclusive) with a diagnosis of 25-hydroxyvitamin D deficiency (S-25(OH) Vitamin D =50 nmol/l) otherwise healthy by medical examination and laboratory parameters.
•2.Those laboratory values outside acceptable range can be considered clinically insignificant as per PI sole discretion.
•3.Subjects must be received both dose of vaccine or tested Covid negative.
•4.Subject’s Body Mass Index (BMI) within normal limit of 18.50-30.00 kg/m2 (inclusive both).
•5.Normal serum calcium concentration (2.2-2.7 nmol/l).
•6.Willingness to comply with the study schedule and procedures.
•7.Patient is willing to provide written informed consent prior to study.

•1.Pregnant and Lactating mothers.
•2.Subject with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and /or renal function, that could interfere with the absorption, metabolism, and /or excretion of the Vitamin D.
•3.Subject with Kidney stone, Anticonvulsant and steroid therapy in any form.
•4.Subject who has taken any prescribed medications beginning two weeks prior to and OTC medications beginning one week prior to first dosing of study.
•5.Use of any Vitamin D supplements or any fortified foods in last 3 months.
•6.Subject with any severe disease and comorbidity.
•7.Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion.
•8.Known hypersensitivity to any ingredient of the study product.
•9.Concomitant Participation in any other clinical trial or in last 90 days.

发起方

CSIR Institute of Himalayan Bioresource Technology