Trial Outcomes & Findings for Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis (NCT NCT01426347)

Results Overview

We measured disease activity as measured by DAS 28 at baseline and at the completion of Randomized Controlled trial, both in the placebo and the active treatment group. We used DAS-28 scores to indicate disease activity. The DAS -28 scale has a minimum of 0 and a maximum of 10, with higher numbers indicating higher disease activity. We used the following cut-offs: Remission (\< 2.6), low disease activity (\< 3.2), moderate disease activity (\< 5.1) and high disease activity (\> 5.1).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

139 participants

Primary outcome timeframe

Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))

Results posted on

2017-03-20

Participant Flow

One hundred thirty-nine (139) participants were enrolled for visit 1, and blood was drawn to determine vitamin D levels. Eighty-three (83) were vitamin D deficient by criteria, vitamin D \< 30 nanogram/milliliter (ng/ml), and entered the randomized controlled trial. The remaining 56 exited the study because they were vitamin D sufficient.

Participant milestones

Participant milestones
Measure	Placebo Group Rheumatoid Arthritis (RA) patients with vitamin D deficiency will be randomized to placebo and active intervention arms. Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm. Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.	Ergocalciferol Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks. Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks
Overall Study STARTED	41	42
Overall Study COMPLETED	34	39
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Group Rheumatoid Arthritis (RA) patients with vitamin D deficiency will be randomized to placebo and active intervention arms. Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm. Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.	Ergocalciferol Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks. Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks
Overall Study Lost to Follow-up	0	3
Overall Study Protocol Violation	2	0
Overall Study Withdrawal by Subject	5	0

Baseline Characteristics

Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Group n=41 Participants RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms. Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm. Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.	Ergocalciferol n=42 Participants Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks. Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks	Total n=83 Participants Total of all reporting groups
Age, Continuous	52.7 years STANDARD_DEVIATION 13.5 • n=5 Participants	52.2 years STANDARD_DEVIATION 12.2 • n=7 Participants	52.5 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	36 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	32 participants n=5 Participants	31 participants n=7 Participants	63 participants n=5 Participants
Race/Ethnicity, Customized Non-caucasian	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))

We measured disease activity as measured by DAS 28 at baseline and at the completion of Randomized Controlled trial, both in the placebo and the active treatment group. We used DAS-28 scores to indicate disease activity. The DAS -28 scale has a minimum of 0 and a maximum of 10, with higher numbers indicating higher disease activity. We used the following cut-offs: Remission (\< 2.6), low disease activity (\< 3.2), moderate disease activity (\< 5.1) and high disease activity (\> 5.1).

Outcome measures

Outcome measures
Measure	Placebo Group n=41 Participants RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms. Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm. Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.	Ergocalciferol n=42 Participants Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks. Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks
Disease Activity Score (DAS) 28 Baseline	3.4 composite score Standard Deviation 1.5	2.8 composite score Standard Deviation 1.3
Disease Activity Score (DAS) 28 16 weeks (end of RCT)	3.5 composite score Standard Deviation 1.5	3.1 composite score Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline and 16 weeks (end of RCT)

Population: For placebo, analysis is based on 26 at baseline and 33 at the end of RCT For treatment, analysis is based on 27 at baseline and 38 at the end of RCT

In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.

Outcome measures

Outcome measures
Measure	Placebo Group n=33 Participants RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms. Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm. Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.	Ergocalciferol n=38 Participants Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks. Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks
Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF) Baseline	1.9 units on a scale Standard Deviation 1.3	1.7 units on a scale Standard Deviation 1.6
Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF) 16 weeks (end of RCT)	1.9 units on a scale Standard Deviation 1.5	1.6 units on a scale Standard Deviation 2.1

Adverse Events

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ergocalciferol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Uzma Jalal Haque

Johns Hopkins University

Phone: 410-550-0578

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place