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Primary Hyperparathyroidism (PHPT): Early Effect of Vitamin D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01329666
Recruitment Status : Withdrawn (Poor enrollment)
First Posted : April 6, 2011
Last Update Posted : March 5, 2015
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Shonni J. Silverberg, Columbia University

Brief Summary:

Primary hyperparathyroidism (PHPT) is a common disease that occurs in 1 in 10,000 people every year. In the presence of this condition, the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. The high levels of parathyroid hormone remove too much calcium from bones, and then deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by excess calcium loss which weakens bone structure. Other affected organs include the skeleton (calcium loss leads to a "weakening" of the skeleton), and the kidneys (high blood calcium can lead to kidney stones).

It is now evident that the majority of patients with even mild Primary Hyperparathyroidism are vitamin D deficient. In 2009, new international guidelines for the management of asymptomatic PHPT direct physicians to measure 25-hydroxyvitamin D (D3 or 25-OHD) in all patients, and to replete the reserve of vitamin D when the level is low (< 20 ng/ml). However, no recommendations for vitamin D repletion are given, because of limited data regarding the effects of vitamin D repletion, appropriate dosing and safety. Therefore, there is an urgent need for data upon which to base such recommendations, as well as are data on the effects of such treatment upon bones.

Subjects with low vitamin D3 levels will be selected for this trial. They will be given enough vitamin D3 to raise their low blood levels from a low to a normal range. The assessments in this study, including the quadruple label bone biopsy, will allow us to document the short term effects of administering vitamin D3 on changes in bone.

All participants enrolled in this trial will be vitamin D3 deficient. Participants will take an antibiotic (tetracycline) 4 times a day to mark the starting point from which bone changes will be assessed. After 3 days of tetracycline, a 12 week course of vitamin D3 or placebo will be initiated. Six of 7 participants will receive the study drug (active vitamin D3), while 1 in 7 will receive a placebo (sugar pill). Ten weeks later, another 3-day course of tetracycline will be given. At the end of 12 weeks, a bone biopsy will be done. A small piece of bone (about the size of a pencil eraser) will be removed from the hip (iliac crest). The bone will be analyzed to determine the effect of vitamin D3 on primary hyperparathyroidism.

There will be 4 study visits: Screening, Baseline, Week 8, and Week 12 when the bone biopsy will be performed.

Study Procedures:

Medical and Social History

Blood tests (drawn at the study center and local Quest Lab)

24-Hour urine collection for calcium and creatinine excretion

Abdominal X-ray (to assess for kidney stones)

Transiliac crest Bone Biopsy

Condition or disease Intervention/treatment Phase
Primary Hyperparathyroidism Hypercalcemia Vitamin D Deficiency Osteoporosis Osteopenia Dietary Supplement: Placebo Dietary Supplement: Vitamin D3 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Early Effect of Vitamin D in Primary Hyperparathyroidism
Study Start Date : May 2010
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: 50,000 IU Vitamin D3 Dietary Supplement: Vitamin D3


50,000 IU/week for 8 weeks

Week 8:

Subjects with D3 less than 30 ng/ml: 50,000 IU/week for 4 weeks.

Subjects with D3 25-OHD at or above 30 ng/ml: 50,000 IU/every 2 weeks for 4 weeks.

Placebo Comparator: Placebo (inactive Vitamin D3) Dietary Supplement: Placebo
Subjects will receive placebo vitamin D3, 1 pill weekly for 12 weeks.

Primary Outcome Measures :
  1. Change in Bone Formation Rate (BFR) [ Time Frame: 12 Weeks ]
    A between group (vitamin D3 vs. placebo) comparison of BFR will be performed at three surfaces, cancellous, intra- and endo-cortical.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Females and males >= 45 years of age
  2. PHPT, defined as elevated PTH with elevated serum calcium
  3. Screening 25-OHD <= 20 ng/ml

Exclusion Criteria:

  1. Pre-menopausal
  2. Serum calcium is >11.5mg/dl.
  3. Urinary calcium is >350 mg/dl.
  4. Active nephrolithiasis
  5. Nephocalcinosis
  6. Known sensitivity to tetracycline (Sumycin)
  7. Familial history of hyperparathyroid syndromes
  8. Bisphosphonate use within past 2 years.
  9. Current use of Prolia.
  10. Current use of Cinacalcet.
  11. Currently using Cimetidine.
  12. Currently use Colestipol.
  13. Currently using Orlistat.
  14. Current or past malignancy, except cured basal or squamous cell skin carcinoma or other cancers that have not recurred for at least five years.
  15. Current tuberculosis, or history of Sarcoidosis, HIV/AIDS, chronic kidney disease (serum creatinine >= 1.5), liver disease, Crohn's Disease, Celiac Disease, or gastric bypass

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01329666

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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Shonni J. Silverberg, MD Columbia University
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Responsible Party: Shonni J. Silverberg, Professor of Medicine, Endocrinology, Columbia University Identifier: NCT01329666    
Other Study ID Numbers: AAAF1846
R01DK084986 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015
Keywords provided by Shonni J. Silverberg, Columbia University:
Primary Hyperparathyroidism
Vitamin D deficiency
Parathyroid Hormone
Bone Density
Vitamin D repletion
Vitamin D Supplements
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Vitamin D Deficiency
Hyperparathyroidism, Primary
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Deficiency Diseases
Nutrition Disorders
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Water-Electrolyte Imbalance
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents