Status unknownPhase 2MS (type not specified)NCT01753375

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

Placebo or sham

  • Placebo

What it measured

Main measures

  • Relapse rate in patients with Multiple Sclerosis

    12 months

    Relapses

Other measures (1)

  • Improvement in the expanded disability status scores after receiving vitamin D3

    12 months

    Disability progression

Who could take part

MS (type not specified) · 18 to 55

Inclusion Criteria: * Age between 18-55 years * Confirmed Multiple Sclerosis diagnosis according to McDonald criteria * Stable neurological functioning for at least one month prior to study entry * Expanded Disability Scale score (EDSS) less than \<_4.0 * Must have had one clinical attack in past two years and at least one new silent T2 or gadolinium-enhancing lesion on MRI within the past one year. * Willing to participate for the entire 52-week period Exclusion Criteria: * pregnant or nursing. * Connective tissue disease (SLE, Sjogren's disease) * Endocrine disease (hyperthyroidism, hyperparathyroidism) * Any medical condition predisposing to hypercalcaemia, nephrolithiasis or renal insufficiency

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

About this trial

In the sponsor's words

Vitamin D3 supplementation reduces the incidence of multiple sclerosis.Although clinical cross-sectional studies have demonstrated vitamin D3 as a positive mediator in preventing relapses and disease progression, prospective randomized control trials are nevertheless necessary to confirm these statements and to determine the most efficacious, safe, and the minimum required doses. This hypothesis is going to be tested through a randomized triple blinded controlled trial in which after randomization, one group of patients will receive vitamin D and second group will receive placebo. Both groups are going to be followed in a similar way over a period of one year with follow ups at 4, 8 and 12 months. Vitamin D levels is going to be performed at 0,4, 12 month interval. MRI is going to be done at the beginning and end of trial.The number of relapses and the physical disability will be calculated through the Expanded disability status scale (EDSS).

Papers

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Related trials

History

    1. Started

      Jan 2013

    2. Main results due

      Jul 2014

    3. Finished

      Oct 2014

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