Investigating the Effects of Hydroxyvitamin D3 on Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2023-12-31

Brief Summary

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

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Detailed Description

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Vitamin D deficiency/insufficiency is a risk factor for developing MS and is linked to increased disease activity in those with established disease. Several clinical trials have already been conducted to consider the effect of vitamin D supplementation on clinical outcomes of the disease but the findings were inconsistent.

This paradox may be explained by supplementation dose, trial duration and also an insufficient rise in serum 25-hydroxyvitamin D to be effective on immunomodulatory pathways and consequent clinical outcomes.

Of note, it was revealed that MS patients have a lower rise in serum 25-hydroxyvitamin D \[25(OH)D\] levels compared with healthy controls (HCs), when given the same amount of oral cholecalciferol supplementation.

Cholecalciferol is the main vitamin D supplement that was used in these trials. When vitamin D3 is ingested, it is incorporated into chylomicrons and enters the lymphatic system. The chylomicrons then enter into the bloodstream via the superior cava. Most of the vitamin D is incorporated into the body fat.

Vitamin D3 in the circulation and the vitamin D3 that is slowly released from the body fat into the circulation is converted in the liver to 25(OH)D3, taking approximately 6-8 weeks to achieve a steady state concentration of 25(OH)D3.

The more rapid increase in serum concentrations of 25(OH)D3, by treatment with calcifediol instead of cholecalciferol, may provide an advantage through rapid entry into its target innate and adaptive immune cells, resulting in the paracrine/autocrine production of 1α,25(OH)2D which interacts with the vitamin D receptor (VDR) to modulate immune function.

Conditions

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Multiple Sclerosis, Relapsing-Remitting Adult ALL Vitamin D3 Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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25(OH)D3 (Calcifediol)

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

Group Type EXPERIMENTAL

25(OH)D3

Intervention Type DIETARY_SUPPLEMENT

calcifediol

Cholecalciferol

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

Group Type EXPERIMENTAL

vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Cholecalciferol

Interventions

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25(OH)D3

calcifediol

Intervention Type DIETARY_SUPPLEMENT

vitamin D3

Cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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vitamin D analog activated 7-dehydrocholesterol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No