NCT01306656

Vitamin D Repletion in Primary Hyperparathyroidism

Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary hyperparathyroidism (PHPT) is a common disease in which the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. In primary hyperparathyroidism, high levels of PTH remove too much calcium from bones and deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by the excess calcium loss which weakens the structure of the bones. Many patients with primary hyperparathyroidism also have low vitamin D (25OHD) levels which is thought to further impair bone health. Recent medical guidelines recommend treating patients with primary hyperparathyroidism who have low vitamin D levels with oral vitamin D but the optimal vitamin D dose and rate of repletion is unclear. It is, therefore, important to determine if replenishing Vitamin D will improve bone health in primary hyperparathyroidism, and if so, to assess the impact of the rate of vitamin D repletion.

Conditions

• Primary Hyperparathyroidism
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	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
OTHER	Placebo	Month 1: Placebo once a week Months 2-6: Placebo once a week
DIETARY_SUPPLEMENT	Vitamin D	Daily multivitamin with 400 IU vitamin D.

Timeline

• Start date: 2011-10-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2011-03-02
• Last updated: 2019-04-16
• Results posted: 2019-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study