Trial Outcomes & Findings for Treatment of Hypovitaminosis D in Rheumatoid Arthritis (NCT NCT00423358)

NCT ID: NCT00423358

Last Updated: 2015-08-24

Results Overview

Serum parathyroid hormone level

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 1 Year
• Results posted on: 2015-08-24

Participant Flow

Participant milestones

Measure	Vitamin D ergocalciferol 50,000 IU Twice monthly Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year	Placebo matching placebo tablet placebo: matching placebo
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Hypovitaminosis D in Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Vitamin D n=11 Participants ergocalciferol 50,000 IU Twice monthly Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year	Placebo n=11 Participants matching placebo tablet placebo: matching placebo	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 12 • n=5 Participants	53 years STANDARD_DEVIATION 11 • n=7 Participants	58 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: Subject data were analyzed using the intent to treat approach.

Serum parathyroid hormone level

Outcome measures

Measure	Vitamin D, n=11 n=11 Participants ergocalciferol 50,000 IU Twice monthly Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year	Placebo, n=11 n=11 Participants matching placebo tablet placebo: matching placebo
Parathyroid Hormone Level	19 pg/mL Standard Deviation 11	20 pg/mL Standard Deviation 11

SECONDARY outcome

Timeframe: 1 Year

Population: Intent to treat analysis

one year change in mean total hip BMD

Outcome measures

Measure	Vitamin D, n=11 n=11 Participants ergocalciferol 50,000 IU Twice monthly Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year	Placebo, n=11 n=11 Participants matching placebo tablet placebo: matching placebo
Bone Mineral Density	0.970 g/cm2 Standard Deviation 0.140	1.151 g/cm2 Standard Deviation 0.168

SECONDARY outcome

Timeframe: 1 Year

Population: Intent to treat analysis

12 month score for physical function domain of SF36 survey; scale 0 to 100 with 0 indicating worst disability and 100 indicating best physical function

Outcome measures

Measure	Vitamin D, n=11 n=11 Participants ergocalciferol 50,000 IU Twice monthly Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year	Placebo, n=11 n=11 Participants matching placebo tablet placebo: matching placebo
Short Form 36 Survey	39.1 units from 0 (worst) to 100 (best) Interval 34.0 to 44.4	47.7 units from 0 (worst) to 100 (best) Interval 42.5 to 52.9

Adverse Events

Vitamin D, n=11

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo, n=11

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vitamin D, n=11 n=11 participants at risk ergocalciferol 50,000 IU Twice monthly Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year	Placebo, n=11 n=11 participants at risk matching placebo tablet placebo: matching placebo
Gastrointestinal disorders GI	9.1% 1/11 • Number of events 1 • Adverse events were queried through specific and open ended questions at each study visit. All AEs after randomization were counted and reported.	0.00% 0/11 • Adverse events were queried through specific and open ended questions at each study visit. All AEs after randomization were counted and reported.

Additional Information

Karen E Hansen, MD, MS

University of Wisconsin

Phone: 608-263-3457

Email: keh@medicine.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place