Vitamin D3 and the Stress-axis in MS
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|ClinicalTrials.gov Identifier: NCT02096133|
Recruitment Status : Terminated (difficulties with inclusion)
First Posted : March 26, 2014
Last Update Posted : January 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Cholecalciferol Other: Placebo comparator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Regulation of the Stress-axis by Vitamin D3 in Subjects With Multiple Sclerosis; a Double-blinded, Randomized, Placebo-controlled Study|
|Study Start Date :||October 13, 2014|
|Actual Primary Completion Date :||November 7, 2016|
|Actual Study Completion Date :||November 7, 2016|
Patients receive 1dd 100ug vitamin D3 (drops) for 16 weeks
Vitamin D3 solution
Other Name: Vigantol Oil
Placebo Comparator: Placebo comparator
placebo drops during 16 weeks
Other: Placebo comparator
- The area under the curve (AUC) of the cortisol day curve [ Time Frame: At baseline and after 16 weeks of supplementation. ]This number is constructed by combining the saliva cortisol levels at awakening, 11:00, 15:00, 20:00, and 22:00 hours (5 time-points).
- The slope of the cortisol day-curve [ Time Frame: At baseline and after 16 weeks of supplementation ]The slope of the day-curve is the slope of the decrease of saliva cortisol measured throughout the cortisol day curve
- The cortisol awakening response [ Time Frame: At baseline and after 16 weeks of supplementation ]The awakening response is described by the rise in saliva cortisol from awakening to 60 minutes after awakening with respectively measurements at awakening, 15 minutes, 30 minutes, 45 minutes and 60 minutes (5 time-points).
- Clinical outcomes on depression [ Time Frame: At baseline and after 16 weeks of supplementation ]The clinical outcomes on depression will be measured by the depression sub-score of HADS and the FSSS fatigue score.
- Efficacy of supplementation [ Time Frame: At baseline and after 16 weeks of supplementation. Side effects will also be checked at 8 weeks of supplementation. ]To measure efficacy 25(OH)D levels will be measured.
- Side effects [ Time Frame: At baseline, after 8 and after 16 weeks ]Side effects will be measured after 8 and 16 weeks of treatment. Serum levels of calcium, albumin and creatinine will be determined, as well as calcium and creatinine levels in urine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096133
|Canisius Wilhelmina Ziekenhuis|
|Academic MS Center Limburg, Orbis Medical Center|
|Sittard-Geleen, Netherlands, 6162 BG|
|Principal Investigator:||Raymond Hupperts, MD, PhD||Academic MS Center Limburg, Orbis MC|