Vitamin D Supplementation After Parathyroid Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Inga-Lena Nilsson, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00982722
First received: September 22, 2009
Last updated: April 10, 2015
Last verified: April 2015
  Purpose

A randomised double blind clinical trial, accepted by the Medical Products Agency and registered in the European Clinical Trials Database. Aims to evaluate the prevalence of vitamin D deficiency in a pHPT population in relation to gender and age, the correlation between vitamin D status, pre- and postoperative parathyroid hormone level and bone density and the correlation between vitamin D status, metabolic, cardiovascular risk factors and QoL aspects before and after parathyroid adenomectomy.


Condition Intervention
Primary Hyperparathyroidism
Drug: cholecalciferol and calcium carbonate
Drug: calcium carbonate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • postoperative parathyroid hormone level [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bone mineral density [ Time Frame: one year ] [ Designated as safety issue: No ]
  • ambulatory blood pressure [ Time Frame: one year ] [ Designated as safety issue: No ]
  • 25-OH Vitamin D [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Calcium [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cholecalciferol and calcium carbonate
cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2
Drug: calcium carbonate
calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery
Other Name: cholecalciferol and calcium carbonate
Active Comparator: calciumcarbonate
calcium carbonate 500 mg x 2
Drug: cholecalciferol and calcium carbonate
cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery
Other Name: calcium carbonate

Detailed Description:

150 PHPT patients were randomized six weeks after surgery, 75 into each group, to 1 year of oral treatment with either calcium carbonate 1 g (500 mg twice daily) alone or calcium carbonate 1 g combined with cholecalciferol 1600 IU (800 IU twice daily). Exclusion criteria were age under 18, manifest osteoporosis at PHPTdiagnosis, persistent hypercalcemia after surgery, postoperative hypocalcemia requiring vitamin D treatment, glomerular filtration rate (GFR) below 40 ml/min, pregnancy, breast feeding, or logistical difficulties, for example living far from the hospital. Included patients had to withdraw any current supplementation with calcium and vitamin D during the study period. All tablets were identical in appearance, the tins were numbered and randomization followed a list compiled by an independent clinical research support organization. The time for randomization was chosen to make sure that the PHPT patients were cured before starting the study medication. Nearly three-quarters of the patients were randomized within 6 weeks after PTX.The primary end point was the change in PTH after PTX and treatment with the study medication. Secondary end points were vitamin D levels, insulin resistance, blood pressure and other cardiovascular risk factors, biochemical markers of bone turnover, bone mineral density and self estimated health related quality of life (SF- 36).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion Criteria:

  • Renal insufficiency
  • Severe osteoporosis
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982722

Locations
Sweden
Karolinska UH
Stockholm, Sweden, 17176
Karolinska University Hospital
Stockholm, Sweden, SE-17176
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Inga-Lena Nilsson, MD, Ass prof Karolinska UH
  More Information

Publications:
Responsible Party: Inga-Lena Nilsson, Assoc prof, senior consultant, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00982722     History of Changes
Other Study ID Numbers: Eudra CT 2007-003691-19
Study First Received: September 22, 2009
Last Updated: April 10, 2015
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska University Hospital:
primary hyperparathyroidism
postoperative vitamin D supplementation

Additional relevant MeSH terms:
Hyperparathyroidism, Primary
Hyperparathyroidism
Endocrine System Diseases
Parathyroid Diseases
Calcium Carbonate
Calcium, Dietary
Cholecalciferol
Vitamin D
Antacids
Bone Density Conservation Agents
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on May 26, 2015