Investigating the Effects of Hydroxyvitamin D3 on Multiple Sclerosis

Status unknownPhase 4Relapsing MSNCT05340985

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

Cholecalciferol
Vitamin D receptor agonist

What it measured

Main measures

Number of relapses
6 months (baseline and end of 6th month) in each intervention arm
Relapses
disability
6 months (baseline and end of 6th month) in each intervention arm
Disability progression
Change in MRI parameters
6 months (baseline and end of 6th month) in each intervention arm
MRI lesions
changing in brain parameters of Diffusion tensor imaging (DTI)
6 months (baseline and end of 6th month) in each intervention arm
MRI lesions
changing in Cognition
6 months (baseline and end of 6th month) in each intervention arm
Thinking and memory
CD4+ T cell response
6 months (baseline and end of 6th month) in each intervention arm
Walking and mobilityImmune response
Differential gene expression
6 months (baseline and end of 6th month) in each intervention arm
Immune response

Other measures (6)

needing hospitalization
6 months (baseline and end of 6th month) in each intervention arm
changing in quality of life
6 months (baseline and end of 6th month) in each intervention arm
Quality of life (reported by participants)
effective in rapidly raising circulating levels of 25(OH)D3
6 months (baseline and end of 6th month) in each intervention arm
changing in the circulating levels of interleukin 17 as a inflammatory marker
6 months (baseline and end of 6th month) in each intervention arm
Immune response
changing in the levels of interleukin 10 as anti- inflammatory marker
6 months (baseline and end of 6th month) in each intervention arm
Immune response
changing in the levels of Tumor Necrosis Factor alpha (TNF-a) as an inflammatory marker related the T-CD4 subsets
6 months (baseline and end of 6th month) in each intervention arm
Immune response

Who could take part

Relapsing MS · 18 to 55

Inclusion Criteria: 1. MS type: relapsing-remitting MS (RRMS) 2. older than 18 year-old 3. Vitamin D deficiency/insufficiency (25(OH)D\<30 ng/ml Exclusion Criteria: 1. medications or disorders that would affect vitamin D metabolism 2. history of other chronic disorders 3. history of conditions that could lead to high serum calcium levels 4. pulse therapy in the last 3 months 5. history of attack in the last 3 months 6. using corticosteroid in the last 3 months 7. be pregnant

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Investigating the effects of hydroxyvitamin D3 on clinical, radiologic and immunomodulatory markers in MS patients: A randomized, clinical trial- a pilot study

Papers

Loading reviews and guidelines…

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History

Started
Jul 2022
Main results due
Jun 2023
Finished
Dec 2023

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