Comparing the effect of high dose vitamin D3 intake on interleukin-10, 17 and quality of life in Multiple Sclerosis patients

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2015
INTERVENTION: Control group: placebo tablet, including inert substance one every five days, made by a Pharmacist Intervention 1: Intervention group 1: 50,000IU vitamin D every five days, for 3 months vitamin D pearl Zahravi Pharmaceuticals. Intervention 2: Control group: placebo tablet, including inert substance one every five days, made by a Pharmacist. Intervention group 1: 50,000IU vitamin D every five days, for 3 months vitamin D pearl Zahravi Pharmaceuticals Placebo Treatment ‐ Drugs CONDITION: Multiple sclerosis. PRIMARY OUTCOME: Interleukin 10, 17. Timepoint: At baseline and after 3 months. Method of measurement: Blood sample. SECONDARY OUTCOME: Quality of life. Timepoint: 3 months. Method of measurement: MSQOL54. INCLUSION CRITERIA: INCLUSION CRITERIA: a definite diagnosis of Relapsing‐remitting Multiple Sclerosis (RRMS) according to Mc Donald criteria? age 18 to 55 years? EDSS (Expanded Disability Status Scale) score of less than 4? no relapse 30 days before inclusion? negative ß‐HCG test for women in child bearing age. Exclusion criteria: pregnancy? lactation? any other disease than Multiple Sclerosis? receiving>4000IU/d vitamin D? past history of renal or hepatic disease? relapse during the study? received corticosteroids in the previous 30 days? Calcium (Ca)>11mg/dl? Aspartate Transaminase(AST) or Alanine Transaminase(ALT)>3 times normal values? alkaline phosphatase (ALP)>2.5 times normal values.
Epistemonikos ID: 01116d43f514ee57cd4a10a5177656ebe0f04ecd
First added on: Mar 31, 2022