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Vitamin D Supplementation After Parathyroid Surgery

Primary Purpose

Primary Hyperparathyroidism

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
cholecalciferol and calcium carbonate
calcium carbonate
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Hyperparathyroidism focused on measuring primary hyperparathyroidism, postoperative vitamin D supplementation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion Criteria:

  • Renal insufficiency
  • Severe osteoporosis
  • Pregnancy

Sites / Locations

  • Karolinska UH
  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cholecalciferol and calcium carbonate

calciumcarbonate

Arm Description

cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2

calcium carbonate 500 mg x 2

Outcomes

Primary Outcome Measures

postoperative parathyroid hormone level
PTH
ambulatory blood pressure
24h blood pressure

Secondary Outcome Measures

bone mineral density
DEXA
25-OH Vitamin D
s-25OHD
Calcium
ionized calcium
Quality of life-self estimating formularies
SF36

Full Information

First Posted
September 22, 2009
Last Updated
February 26, 2019
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00982722
Brief Title
Vitamin D Supplementation After Parathyroid Surgery
Official Title
Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 4, 2018 (Actual)
Study Completion Date
May 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism
Keywords
primary hyperparathyroidism, postoperative vitamin D supplementation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cholecalciferol and calcium carbonate
Arm Type
Experimental
Arm Description
cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2
Arm Title
calciumcarbonate
Arm Type
Active Comparator
Arm Description
calcium carbonate 500 mg x 2
Intervention Type
Drug
Intervention Name(s)
cholecalciferol and calcium carbonate
Other Intervention Name(s)
calcium carbonate
Intervention Description
cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery
Intervention Type
Drug
Intervention Name(s)
calcium carbonate
Other Intervention Name(s)
cholecalciferol and calcium carbonate
Intervention Description
calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery
Primary Outcome Measure Information:
Title
postoperative parathyroid hormone level
Description
PTH
Time Frame
3 months
Title
ambulatory blood pressure
Description
24h blood pressure
Time Frame
one year
Secondary Outcome Measure Information:
Title
bone mineral density
Description
DEXA
Time Frame
one year
Title
25-OH Vitamin D
Description
s-25OHD
Time Frame
3 months
Title
Calcium
Description
ionized calcium
Time Frame
6 weeks
Title
Quality of life-self estimating formularies
Description
SF36
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary hyperparathyroidism subjected to parathyroid surgery Exclusion Criteria: Renal insufficiency Severe osteoporosis Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inga-Lena Nilsson, MD, Ass prof
Organizational Affiliation
Karolinska UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska UH
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24115138
Citation
Norenstedt S, Pernow Y, Zedenius J, Nordenstrom J, Saaf M, Granath F, Nilsson IL. Vitamin D supplementation after parathyroidectomy: effect on bone mineral density-a randomized double-blind study. J Bone Miner Res. 2014 Apr;29(4):960-7. doi: 10.1002/jbmr.2102.
Results Reference
result
PubMed Identifier
24026893
Citation
Norenstedt S, Pernow Y, Brismar K, Saaf M, Ekip A, Granath F, Zedenius J, Nilsson IL. Primary hyperparathyroidism and metabolic risk factors, impact of parathyroidectomy and vitamin D supplementation, and results of a randomized double-blind study. Eur J Endocrinol. 2013 Oct 21;169(6):795-804. doi: 10.1530/EJE-13-0547. Print 2013 Dec.
Results Reference
result
PubMed Identifier
25414430
Citation
Aberg V, Norenstedt S, Zedenius J, Saaf M, Nordenstrom J, Pernow Y, Nilsson IL. Health-related quality of life after successful surgery for primary hyperparathyroidism: no additive effect from vitamin D supplementation: results of a double-blind randomized study. Eur J Endocrinol. 2015 Feb;172(2):181-7. doi: 10.1530/EJE-14-0757. Epub 2014 Nov 20.
Results Reference
result
PubMed Identifier
26435425
Citation
Nilsson IL, Norenstedt S, Granath F, Zedenius J, Pernow Y, Larsson TE. FGF23, metabolic risk factors, and blood pressure in patients with primary hyperparathyroidism undergoing parathyroid adenomectomy. Surgery. 2016 Jan;159(1):211-7. doi: 10.1016/j.surg.2015.06.057. Epub 2015 Oct 2.
Results Reference
result
PubMed Identifier
28522130
Citation
Nilsson IL, Norenstedt S, Zedenius J, Pernow Y, Branstrom R. Primary hyperparathyroidism, hypercalciuria, and bone recovery after parathyroidectomy. Surgery. 2017 Aug;162(2):429-436. doi: 10.1016/j.surg.2017.02.017. Epub 2017 May 15.
Results Reference
result

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Vitamin D Supplementation After Parathyroid Surgery

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