Trial Outcomes & Findings for Vitamin D Repletion in Primary Hyperparathyroidism (NCT NCT01306656)

NCT ID: NCT01306656

Last Updated: 2019-04-16

Results Overview

This is designed to measure how many participants will achieve PTH \> 65 pg/mL.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 9 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-04-16

Participant Flow

Participant milestones

Measure	10,000 IU Vitamin D3 + Multivitamin 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D 10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.	Placebo + Multivitamin Placebo plus a multivitamin with 400 IU vitamin D Placebo: Month 1: Placebo once a week Months 2-6: Placebo once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.
Overall Study STARTED	7	2
Overall Study COMPLETED	6	2
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	10,000 IU Vitamin D3 + Multivitamin 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D 10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.	Placebo + Multivitamin Placebo plus a multivitamin with 400 IU vitamin D Placebo: Month 1: Placebo once a week Months 2-6: Placebo once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Vitamin D Repletion in Primary Hyperparathyroidism

Baseline characteristics by cohort

Measure	10,000 IU Vitamin D3 + Multivitamin n=7 Participants 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D 10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.	Placebo + Multivitamin n=2 Participants Placebo plus a multivitamin with 400 IU vitamin D Placebo: Month 1: Placebo once a week Months 2-6: Placebo once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.	Total n=9 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	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Study enrollment did not reach the required number of subjects; the analysis results would not have been reliable or have enough statistical power. Therefore, samples were not processed and data was not available for analysis.

This is designed to measure how many participants will achieve PTH > 65 pg/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Study enrollment did not reach the required number of subjects; the analysis results are not reliable or have enough statistical power.

Measured by dual-energy x-ray absorptiometry (DEXA) scan

Outcome measures

Measure	10,000 IU Vitamin D3 + Multivitamin n=6 Participants 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D 10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.	Placebo + Multivitamin n=2 Participants Placebo plus a multivitamin with 400 IU vitamin D Placebo: Month 1: Placebo once a week Months 2-6: Placebo once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.
Areal Bone Mineral Density of the Lumbar Spine	-.98777 percentage of change Standard Deviation 1.662643	1.442861 percentage of change Standard Deviation 4.376592

SECONDARY outcome

Timeframe: 6 months

Population: Study enrollment did not reach the required number of subjects; the analysis results are not reliable nor have enough statistical power.

Measured by high resolution peripheral quantitative computed tomography

Outcome measures

Measure	10,000 IU Vitamin D3 + Multivitamin n=5 Participants 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D 10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.	Placebo + Multivitamin n=2 Participants Placebo plus a multivitamin with 400 IU vitamin D Placebo: Month 1: Placebo once a week Months 2-6: Placebo once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.
Trabecular Bone Density at the Forearm	-1.00345 percentage of change Standard Deviation 3.912386	-2.59816 percentage of change Standard Deviation 0.583978

SECONDARY outcome

Timeframe: 1 month, 3 months, 6 months

Population: Data is provided for 6 out of the 7 participants in Group 1 due to that 1 participant became lost to follow-up and did not complete lab testing at Month 3 and 6.

This is designed to measure how the study treatment will affect urinary calcium level over time.

Outcome measures

Measure	10,000 IU Vitamin D3 + Multivitamin n=6 Participants 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D 10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.	Placebo + Multivitamin n=2 Participants Placebo plus a multivitamin with 400 IU vitamin D Placebo: Month 1: Placebo once a week Months 2-6: Placebo once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.
Change in Urinary Calcium Level 6-month	195.17 mg/day Interval 12.0 to 387.0	50.5 mg/day Interval 30.0 to 71.0
Change in Urinary Calcium Level 1-month	182.67 mg/day Interval 9.0 to 453.0	154 mg/day Interval 76.0 to 232.0
Change in Urinary Calcium Level 3-month	172.67 mg/day Interval 6.0 to 282.0	115.5 mg/day Interval 51.0 to 180.0

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group 1 n=7 participants at risk 10,000 IU Vitamin D3 plus a multivitamin with 400 IU vitamin D 10,000 IU Vitamin D3: Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.	Group 2 n=2 participants at risk Placebo plus a multivitamin with 400 IU vitamin D Placebo: Month 1: Placebo once a week Months 2-6: Placebo once a week Vitamin D: Daily multivitamin with 400 IU vitamin D.
Renal and urinary disorders Infection	0.00% 0/7 • 6 months Definitions do not differ from those of the ClinicalTrials.gov definitions.	50.0% 1/2 • Number of events 1 • 6 months Definitions do not differ from those of the ClinicalTrials.gov definitions.
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 1 • 6 months Definitions do not differ from those of the ClinicalTrials.gov definitions.	0.00% 0/2 • 6 months Definitions do not differ from those of the ClinicalTrials.gov definitions.
Renal and urinary disorders Kidney Stones	14.3% 1/7 • Number of events 1 • 6 months Definitions do not differ from those of the ClinicalTrials.gov definitions.	0.00% 0/2 • 6 months Definitions do not differ from those of the ClinicalTrials.gov definitions.

Additional Information

Shonni Silverberg, MD

Columbia University

Phone: 212-305-6291

Email: sjs7@cumc.columbia.edu

Results disclosure agreements

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