Changes to the immune system after vitamin D supplementation in healthy individuals and people with multiple sclerosis

Not Applicable

• Conditions: Multiple sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12621000597897
• Lead Sponsor: Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-19
• Study Completion: 2022-07-08
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

•Aged between 18 and 65 years old inclusive
•No Vitamin D supplementation for at least 1 month prior
•Be willing to avoid open-label Vitamin D supplementation and external serum Vitamin D testing for the duration of the study
•Be willing to avoid the use of sunbeds
•Not currently pregnant or planning to become pregnant during the study period, and willing to use effective contraceptive methods for the duration of the study
•Be able and willing to comply with all study procedures
•Be able to give informed consent and sign the informed consent form

Additional inclusion criteria for healthy participants are:
•No diagnosis of MS or CIS, or significant chronic disease

Additional inclusion criteria for participants with MS are:
•Relapsing-remitting MS diagnosed within the previous 10 years, meeting McDonald criteria for the diagnosis of MS
•Either on no DMT or on natalizumab prior to and during the study period
•Diagnosed and managed by a neurologist

Exclusion Criteria

•Currently pregnant or breastfeeding
•A history of primary hyperparathyroidism or any other condition causing hypercalcaemia
•A history of sarcoidosis
•A history of renal calculi
•A history of treated osteoporosis or any other condition requiring treatment with calcium, Vitamin D, bisphosphonates, strontium ranelate, denosumab, raloxifene, calcitriol or teriparetide
•Hypercalcaemia, abnormal eGFR (<60 mL/min/1.73m2) or an elevated uric acid laboratory value on screening blood tests
•Other neurological, psychiatric or other disease comorbidities which, in the opinion of the investigator, could impair capacity to provide informed consent, interfere with study compliance, or impair the participant’s ability to comply with study protocol
•Current enrolment in another drug interventional trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in gene expression of immune cell subsets. Gene expression will be assessed by RNA-sequencing of immune cell subsets isolated from collected peripheral blood samples. <br>[Baseline, 4 weeks];Change in peripheral immune cell phenotype, assessed by flow cytometry of blood samples. [Baseline, 4 weeks]

Secondary Outcome Measures

Name	Time	Method
il[Nil]