Investigating the Effects of Hydroxyvitamin D3 on Multiple Sclerosis

NCT05340985 | Unknown Phase 4

• 1 other identifier: 1400-3-233-56129
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Sclerosis, Relapsing-Remitting; Adult ALL; Vitamin D3 Deficiency

Outcome Measures

Primary Outcomes (7)

• Number of relapses

  neurologic symptoms lasting more than 24 hours which occur at least 30 days after the onset of a preceding event

  6 months (baseline and end of 6th month) in each intervention arm

• disability

  Change in expanded disability status scale (EDSS) according to Kurtzke 1983. The minimum is 0 (no disability) and maximum value is 10 (Death due to MS)- higher scores mean a worse outcome.

  6 months (baseline and end of 6th month) in each intervention arm

• Change in MRI parameters

  new lesions on T2 weighted images, gadolinium enhancing lesions in T1-weighted images

  6 months (baseline and end of 6th month) in each intervention arm

• changing in brain parameters of Diffusion tensor imaging (DTI)

  the integrity of white matter (WM) by analyzing WM microstructure through DTI

  6 months (baseline and end of 6th month) in each intervention arm

• changing in Cognition

  Changing in cognitive functions by the Minimal Assessment of Cognitive Function in MS (MACFIMS) battery. The lower the score the more disfunction. MACFIMS is consisting of 7 subtests including: 1. the California Verbal Learning Test second edition (CVLT-II), with the range score: 0-80 2. the Paced Auditory Serial Addition Test (PASAT), with the range score: 0-16 3. the Symbol Digit Modalities Test (SDMT), with the range score: 0-110 4. the Brief Visuospatial Memory Test-Revised (BVMT-R), with the range score: 0-36 5. the Controlled Oral Word Association Test (COWAT), with the range score: 0-12 6. the Delis-Kaplan Executive Function System (DKEFS) sorting Test, with the range score: 0- undetermined 7. the Judgment of Line Orientation Test (JLO), with the range score: 0-30 The higher score in each subtest means the better cognitive function

  6 months (baseline and end of 6th month) in each intervention arm

• CD4+ T cell response

  After six months, changing the balance of Th17 and Tregs subtypes of CD4+ T cells. Detecting interleukin (IL) 17 -expressing T cells and Tregs expressing T cells by flow cytometry.

  6 months (baseline and end of 6th month) in each intervention arm

• Differential gene expression

  After six months of 25-hydroxy vitamin D supplementation, the differentially expressed genes (DEGs) in peripheral blood mononuclear cells at the transcriptome level will be considered by RNA-seq

  6 months (baseline and end of 6th month) in each intervention arm

Secondary Outcomes (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

• 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

• changing in the levels of interleukin 10 as anti- inflammatory marker

  6 months (baseline and end of 6th month) in each intervention arm

Study Arms (2)

25(OH)D3 (Calcifediol)

EXPERIMENTAL

50 micrograms per day 25(OH)D3 or vitamin D hydroxylated for 24 weeks

Dietary Supplement: 25(OH)D3

Cholecalciferol

EXPERIMENTAL

50 micrograms (2000IU) per day Cholecalciferol for 24 Weeks

Dietary Supplement: vitamin D3

Interventions

25(OH)D3 DIETARY_SUPPLEMENT

calcifediol

Also known as: vitamin D analog

25(OH)D3 (Calcifediol)

vitamin D3 DIETARY_SUPPLEMENT

Cholecalciferol

Also known as: activated 7-dehydrocholesterol

Cholecalciferol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: based on ID
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• MS type: relapsing-remitting MS (RRMS)
• older than 18 year-old
• Vitamin D deficiency/insufficiency (25(OH)D\<30 ng/ml

You may not qualify if:

• medications or disorders that would affect vitamin D metabolism
• history of other chronic disorders
• history of conditions that could lead to high serum calcium levels
• pulse therapy in the last 3 months
• history of attack in the last 3 months
• using corticosteroid in the last 3 months
• be pregnant

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Boston University: collaborator

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Calcifediol; Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Mohamadali Sahraian, MD

  Multiple Sclerosis Research Center, Tehran University of Medical Sciences

  STUDY CHAIR

• Zhila Maghbooli, PhD

  Multiple Sclerosis Research Center, Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Michael F Holick, PhD,MD

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhila Maghbooli

CONTACT

00989121973516; zhilayas@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All participants at the MS clinic will be blinded to trial intervention allocation. The main outcomes will be evaluated by neurologists. Investigator is also blind; two type of vitamin D; 25(OH)D3 and cholecalciferol capsules with similar shape and color.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized clinical trial with a parallel group and allocation 1:1.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 22, 2022
• Study Start: July 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 22, 2022

Record last verified: 2022-02