Assessment of safety and tolerability after administration of Shiitake Mushroom powder in form of soup over 6 week’s period.
- Registration Number
- CTRI/2022/12/048323
- Lead Sponsor
- CSIR Institute of Himalayan Bioresource Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportions of subjects with Total 25-hydroxyvitamin D, 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 levels in serum of =50 nmol/l at Day 8, Day 15, Day 22, Day 29 and Day 36 post- dose in three arms.Timepoint: Day 8, Day 15, Day 22, Day 29 and Day 36
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil