None listed
Conditions
Brief summary
Vitamin D is a vitamin with roles in regulation of calcium and phosphate in the body and in bone health. It has also been found to regulate cell functions, including those of the immune system. Multiple sclerosis (MS) is one the most common disabling neurological conditions among young adults. Lower vitamin D levels are associated with a higher risk of developing MS. Our study aims to elucidate the effect that Vitamin D supplementation has on the immune cells firstly in healthy participants, following which we will aim to explore this in people with MS as well.
Interventions
Vitamin D3 10,000 IU oral tablet daily for 4 weeks.
At week 4 follow-up visit, participant's compliance will be assessed by participant self-report and by pill count.
Sponsors
Alfred Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Outcome results
None listed