Columbia University Medical Center
New York, 10032, United States
NCT Number: NCT01306656
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
New York, 10032, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Month 1: 20,000 IU vitamin D3 once a week
Months 2-6: 10,000 IU vitamin D3 once a week
Other names: Cholecalciferol-D3
Month 1: Placebo once a week
Months 2-6: Placebo once a week
Other names: Placebo pill
Daily multivitamin with 400 IU vitamin D.
Other names: cholecalciferol
Time frame: 6 months
This is designed to measure how many participants will achieve PTH > 65 pg/mL.
Time frame: 6 months
Measured by dual-energy x-ray absorptiometry (DEXA) scan
Time frame: 6 months
Measured by high resolution peripheral quantitative computed tomography
Time frame: 1 month, 3 months, 6 months
This is designed to measure how the study treatment will affect urinary calcium level over time.
Columbia University
Other
Randomized Controlled Trial of Vitamin D Repletion Regimens in Primary Hyperparathyroidism
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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