Trial Outcomes & Findings for Vitamin D Repletion in Stone Formers With Hypercalciuria (NCT NCT01295879)

NCT ID: NCT01295879

Last Updated: 2012-10-23

Results Overview

Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2012-10-23

Participant Flow

Participant milestones

Measure	Ergocalciferol Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Repletion in Stone Formers With Hypercalciuria

Baseline characteristics by cohort

Measure	Ergocalciferol n=29 Participants Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	48 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones

Outcome measures

Measure	Ergocalciferol n=29 Participants Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
Change in 24 Hour Urine Calcium	2 mg/day Standard Deviation 71

SECONDARY outcome

Timeframe: 8 weeks

Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones

Outcome measures

Measure	Ergocalciferol n=29 Participants Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
Change in 24 Hour Urine Supersaturation of Calcium Oxalate	-1 (unitless) Standard Deviation 3.5

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	Ergocalciferol n=29 Participants Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
Recurrence of Kidney Stones	0 # of stone recurrences

Adverse Events

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

David E. Leaf, M.D., Renal Fellow

Brigham and Women's Hospital

Phone: 617-732-5951

Email: DELEAF@partners.org

Results disclosure agreements

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