NCT01728922: CISAVID

Dose-related Effects of Vitamin D3 on Immune Responses in Patients With Clinically Isolated Syndrome

Completed Phase 1, PHASE2 Last updated 3 May 2017

What this trial tests

Phase 1, PHASE2 trial testing 5000IU vitamin D in Clinically Isolated Syndrome in 64 participants. Completed in 5 June 2016.

Timeline

6 November 2012

Primary endpoint
5 June 2015

5 June 2016

Quick facts

Lead sponsor	University College Dublin
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	64
Start date	6 November 2012
Primary completion	5 June 2015
Estimated completion	5 June 2016
Sites	1 location across Ireland

Drugs / interventions tested

• 5000IU vitamin D
• 10000IU vitamin D
• Placebo

Conditions studied

• Clinically Isolated Syndrome — all drugs for Clinically Isolated Syndrome →
• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

University College Dublin

Who can join

Adults 18 to 55, any sex, with Clinically Isolated Syndrome or Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to assess the immune response to vitamin D supplementation at two doses (5,000 IU and 10,000 IU daily) in both healthy controls and patients with clinically isolated syndrome compared to placebo. Secondary endpoints include (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and evidence of new lesions on MRI (McDonald's MS), 2) Safety of doses used

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vitamin D for the management of multiple sclerosis.
   Jagannath VA, Filippini G, Di Pietrantonj C, Asokan GV, et al · · 2018 · cited 76× · PMID 30246874 · DOI 10.1002/14651858.cd008422.pub3
2. Vitamin D in Neurological Diseases.
   Plantone D, Primiano G, Manco C, Locci S, et al · · 2022 · cited 38× · PMID 36613531 · DOI 10.3390/ijms24010087
3. Can we prevent or treat multiple sclerosis by individualised vitamin D supply?
   Dörr J, Döring A, Paul F. · · 2013 · cited 33× · PMID 23356351 · DOI 10.1186/1878-5085-4-4
4. Effects of vitamin D₃ in clinically isolated syndrome and healthy control participants: A double-blind randomised controlled trial.
   O'Connell K, Sulaimani J, Basdeo SA, Kinsella K, et al · · 2017 · cited 19× · PMID 28975037 · DOI 10.1177/2055217317727296
5. Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome and healthy control participants: study protocol for an exploratory randomized double- blind placebo-controlled trial.
   O'Connell K, Kelly S, Kinsella K, Jordan S, et al · · 2013 · cited 16× · PMID 23981773 · DOI 10.1186/1745-6215-14-272
6. Clinical and Imaging Outcomes after Vitamin D Supplementation in Patients with Multiple Sclerosis: A Systematic Review.
   Langlois J, Denimal D. · · 2023 · cited 10× · PMID 37111166 · DOI 10.3390/nu15081945
7. 2014 Joint ACTRIMS-ECTRIMS Meeting (MSBoston 2014) MS Journal Online: Poster Session 1.
   · 2014 · cited 8× · PMID 25205048 · DOI 10.1177/1352458514546077
8. 2014 multiple sclerosis therapeutic update.
   Cree BA. · · 2014 · cited 2× · PMID 24707333 · DOI 10.1177/1941874414525410