Trial Outcomes & Findings for Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects (NCT NCT00427037)

NCT ID: NCT00427037

Last Updated: 2015-07-22

Results Overview

25-hydroxyvitamin D measured in serum by ELISA

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2015-07-22

Participant Flow

Study subjects were recruited from Nephrology and Endocrinology clinics at Emory University School of Medicine

Participant milestones

Measure	Placebo This is a matching placebo	Cholecalciferol This is vitamin D3 or Cholecalciferol
Overall Study STARTED	17	17
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects

Baseline characteristics by cohort

Measure	Placebo n=17 Participants This is a matching placebo	Cholecalciferol n=17 Participants This is vitamin D3 or Cholecalciferol	Total n=34 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	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	59.5 years STANDARD_DEVIATION 10.4 • n=5 Participants	62.2 years STANDARD_DEVIATION 11 • n=7 Participants	60.8 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

25-hydroxyvitamin D measured in serum by ELISA

Outcome measures

Measure	Placebo n=10 Participants Placebo Placebo: identical placebo pill orally by mouth	Cholecalciferol n=10 Participants D3 Cholecalciferol: 50,000 IU weekly by mouth
25-hydroxyvitamin D Baseline	18.6 ng/mL Interval 12.8 to 27.1	17.3 ng/mL Interval 11.8 to 25.2
25-hydroxyvitamin D 12 weeks	19.5 ng/mL Interval 13.4 to 28.4	49.4 ng/mL Interval 33.9 to 72.0

SECONDARY outcome

Timeframe: 12 weeks

Blood levels of C-telopeptide

Outcome measures

Measure	Placebo n=8 Participants Placebo Placebo: identical placebo pill orally by mouth	Cholecalciferol n=9 Participants D3 Cholecalciferol: 50,000 IU weekly by mouth
Bone Turnover Marker-CTX	0.24 pg/mL Interval 0.14 to 0.4	0.29 pg/mL Interval 0.18 to 0.49

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Cholecalciferol

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=17 participants at risk This is a matching placebo	Cholecalciferol n=17 participants at risk This is vitamin D3 or Cholecalciferol
General disorders Death	5.9% 1/17 • Number of events 1 • 3 Months	5.9% 1/17 • Number of events 1 • 3 Months

Other adverse events

Adverse event data not reported

Additional Information

Vin Tangpricha

Emory University School of Medicine

Phone: 404-727-7254

Email: vin.tangpricha@emory.edu

Results disclosure agreements

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