Premium
A Phase I/II Dose‐Escalation Trial of Vitamin D3 with Calcium Supplementation in Patients with Multiple Sclerosis
Author(s) -
Kimball Samantha M,
Burton Jodie,
Vieth Reinhold,
O'Connor Paul
Publication year - 2008
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.22.1_supplement.157.2
Subject(s) - medicine , vitamin d and neurology , vitamin , gastroenterology , clinical endpoint , randomized controlled trial , calcium , multiple sclerosis , vitamin d deficiency , interim analysis , expanded disability status scale , incidence (geometry) , immunology , physics , optics
There is evidence to suggest that vitamin D nutritional status may influence the development and progression of multiple sclerosis (MS). To characterize the safety profile of high‐dose oral vitamin D3 in MS, we conducted a phase I/II dose‐escalation trial of vitamin D3 with calcium supplementation in patients with MS. In 52‐week trial patients with MS were matched (age, gender, disease duration, Expanded Disability Status Scale, disease modifying therapy, and MS subtype), stratified, and randomized to treatment or control. The treatment group received escalating doses of vitamin D3 (4,000â 40,000 IU/d) and calcium (1200mg/d). The primary endpoint was change in serum calcium concentrations in the treatment group. Baseline and end‐of‐trial measures of disease progression will be compared. Immune system biomarkers will be compared between baseline and end‐of‐study within the treatment group and between treatment and control subjects. Interim analysis: 9/25 treatment patients remain in‐study while 15/25 have finished. Serum and urine calcium levels have remained within normal ranges (2.2â 2.6mmol/L) for all participants with no incidence of hypercalcemia or hypercalciura. There was no significant difference between control and treatment groups. Mean serum 25(OH)D concentrations have increased significantly from 73.5 to 402.1 nmol/L (p<0.001) at the highest dose (n=14). Further results to follow.