CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 9 enrolled
Drug / intervention
10,000 IU Vitamin D3 +2 moredrug
Likely dose
10,000 IU Vitamin D3from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01306656
NCT01306656Phase 4Completed
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Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism

Columbia University·interventional·Posted Mar 2, 2011·Updated Apr 16, 2019

In Brief

A Phase 4 clinical trial evaluating 10,000 IU Vitamin D3, Placebo, and 1 other intervention for Primary Hyperparathyroidism and Vitamin D Deficiency. Completed, enrolled 9 participants across 1 site.

Detailed Summary

This study will look at the effect of 2 treatment regimens that contain vitamin D in a six-month treatment trial of patients with PHPT who are vitamin D deficient. Patients will be assigned randomly to one of 2 regimens, and will be followed with tests of their blood, urine and bones. This study should provide important information on the effect of vitamin D therapy in patients with PHPT. In addition, data from this study will guide physicians as to how best to treat their patients who have PHPT and vitamin D deficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Hyperparathyroidism, Vitamin D Deficiency
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2011
Enrollment StartOct 1, 2011
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.3 years ago

Interventions

10,000 IU Vitamin D3drug

Month 1: 20,000 IU vitamin D3 once a week Months 2-6: 10,000 IU vitamin D3 once a week

Placeboother

Month 1: Placebo once a week Months 2-6: Placebo once a week

Vitamin Ddietary

Daily multivitamin with 400 IU vitamin D.