An initial, short-duration study of vitamin D versus an inactive therapy on the ability of the human immune system to counteract the effects of Multiple Sclerosis on the brain and the effects of vitamin D on the immune system in healthy individuals.

Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome or early multiple sclerosis and healthy control participants. An exploratory randomised double blind placebo controlled study - N/A

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000635-68-IE

Enrollment

Unknown

Registered

2012-02-09

Start date

2012-09-19

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis MedDRA version: 14.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Vigantol Product Name: N/A Product Code: N/A Pharmaceutical Form: Oral drops, solution Pharmaceutical form of the placebo: Oral drops, solution Route of administration of the placebo: Oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) Healthy volunteer participants. The healthy control subjects will be specifically recruited from and junior hospital doctors, nursing and administrative staff at St Vincent's University Hospital in the age range 25-40 years since the CIS/MS population will have a mean age of 30-32 years based on natural history data. The gender ratio of the control subjects will be 2:1: F: M since that is the ratio found in MS/CIS patients. b) Patients (n=45) with a clinically isolated syndrome and two or more than two T2 lesions on MRI brain scan or relapsing-remitting MS (McDonald’s criteria) within 5 years of onset, aged 18-55yrs and not receiving any disease modifying therapy. c) Although vitamin D has no effect on pregnancy, pregnancy affects MS activity and immunological measures, thus female CIS/MS patients and control participants will be requested to avoid becoming pregnant during the study. d) Written informed consent from all participants (patients and healthy volunteers) after they have read the participant information leaflet. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 84 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a) Patients in whom any disease other than MS could explain their signs and symptoms. b) Patients with known disease of the parathyroids, a history of vitamin D intolerance, sarcoidosis, a history of hypercalcaemia of any cause. c) Patients with a baseline abnormality in serum urea, creatinine, calcium, parathormone. d) Patients on thiazide diuretics (hypercalcaemia risk). e) Occurrence of a relapse less than six weeks prior to entry to study. f) Previous treatment with beta-interferons or glatiramer acetate or steroids in the last three months. g) Any previous treatment with mitoxantrone or other immunosuppressant. h) Patients or controls already on supplemental vitamin D.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effects of vitamin D supplementation at two doses a) 4,667 IU daily b) 9,333 IU daily compared to c) placebo over a four and six-month period on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome or early MS not treated with disease modifying therapies 2) healthy control participants ;Secondary Objective: 1) To determine whether there is a dose response effect of supplementation using 5,000 IU and 10,000 IU of vitamin D versus placebo over four and six months on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome (CIS) or early MS not treated with disease modifying therapies (DMTs) 2) healthy control participants 2) To establish whether there is a clinical response to vitamin D measured by a) change in the number of T2 lesions on MRI scanning at six months compared to baseline b) freedom from relapses in treated (both 5,000 IU and 10,000 IU) CIS/MS patients versus CIS/MS patients receiving placebo. ;Primary end point(s): 1 Primary endpoint: To determine the effects of vitamin D supplementation at two doses a) 4,667 IU daily b) 9,333 IU daily compared to c) placebo over a four and six-month period on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome (CIS) or early MS not treated with disease modifying therapies (DMTs) 2) healthy control participants;Timepoint(s) of evaluation of this end point: Six months	—

Measure

Time frame

Main Objective: To determine the effects of vitamin D supplementation at two doses a) 4,667 IU daily b) 9,333 IU daily compared to c) placebo over a four and six-month period on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome or early MS not treated with disease modifying therapies 2) healthy control participants ;Secondary Objective: 1) To determine whether there is a dose response effect of supplementation using 5,000 IU and 10,000 IU of vitamin D versus placebo over four and six months on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome (CIS) or early MS not treated with disease modifying therapies (DMTs) 2) healthy control participants 2) To establish whether there is a clinical response to vitamin D measured by a) change in the number of T2 lesions on MRI scanning at six months compared to baseline b) freedom from relapses in treated (both 5,000 IU and 10,000 IU) CIS/MS patients versus CIS/MS patients receiving placebo. ;Primary end point(s): 1 Primary endpoint: To determine the effects of vitamin D supplementation at two doses a) 4,667 IU daily b) 9,333 IU daily compared to c) placebo over a four and six-month period on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome (CIS) or early MS not treated with disease modifying therapies (DMTs) 2) healthy control participants;Timepoint(s) of evaluation of this end point: Six months

—

Secondary

Measure	Time frame
Secondary end point(s): 1) To determine whether there is a dose response effect of supplementation using 4,667 IU and 9,333 IU of vitamin D versus placebo over four and six months on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome (CIS) or early MS not treated with disease modifying therapies (DMTs) 2) healthy control participants 2) To establish whether there is a clinical response to vitamin D measured by a) change in the number of T2 lesions on MRI scanning at six months compared to baseline b) freedom from relapses in treated (both 5,000 IU and 10,000 IU) CIS/MS patients versus CIS/MS patients receiving placebo. ;Timepoint(s) of evaluation of this end point: Six months	—

Measure

Time frame

Secondary end point(s): 1) To determine whether there is a dose response effect of supplementation using 4,667 IU and 9,333 IU of vitamin D versus placebo over four and six months on the frequency of CD4 T cell subsets and cytokine responses by PBMC in 1) patients with the clinically isolated syndrome (CIS) or early MS not treated with disease modifying therapies (DMTs) 2) healthy control participants 2) To establish whether there is a clinical response to vitamin D measured by a) change in the number of T2 lesions on MRI scanning at six months compared to baseline b) freedom from relapses in treated (both 5,000 IU and 10,000 IU) CIS/MS patients versus CIS/MS patients receiving placebo. ;Timepoint(s) of evaluation of this end point: Six months

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Countries

Ireland

Contacts

Public ContactNeurology Department

St Vincent's University Hospital

n.neuadcc@st-vincents.ie0035312214179

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 22, 2026