None listed
Conditions
Interventions
Intervention1: Radiated Shiitake Mushroom soup (30000 IU): Investigational product will be prepared freshly and content of the IP will be mixed in 300 ml of hot water and should be cooked with constan
Sponsors
CSIR Institute of Himalayan Bioresource Technology
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactManoj karwa
CSIR Institute of Himalayan Bioresource Technology
Outcome results
None listed