Vitamin D Supplementation After Parathyroid Surgery

Sponsor

Karolinska University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00982722

Collaborator

(none)

150

Enrollment

Locations

Arms

121.1

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Hyperparathyroidism	Drug: cholecalciferol and calcium carbonate Drug: calcium carbonate	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

May 4, 2018

Actual Study Completion Date :

May 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: calcium carbonate

Arm

Intervention/Treatment

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 Names:

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 Names:

calcium carbonate

Outcome Measures

Primary Outcome Measures

postoperative parathyroid hormone level [3 months]
PTH
ambulatory blood pressure [one year]
24h blood pressure

Secondary Outcome Measures

bone mineral density [one year]
DEXA
25-OH Vitamin D [3 months]
s-25OHD
Calcium [6 weeks]
ionized calcium
Quality of life-self estimating formularies [one year]
SF36

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion Criteria:

Renal insufficiency
Severe osteoporosis
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska UH	Stockholm		Sweden	17176
2	Karolinska University Hospital	Stockholm		Sweden	SE-17176

Sponsors and Collaborators

Karolinska University Hospital

Investigators

Principal Investigator: Inga-Lena Nilsson, MD, Ass prof, Karolinska UH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Inga-Lena Nilsson, Assoc prof, senior consultant, Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT00982722

Other Study ID Numbers:

Eudra CT 2007-003691-19

First Posted:

Sep 23, 2009

Last Update Posted:

Feb 28, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Inga-Lena Nilsson, Assoc prof, senior consultant, Karolinska University Hospital

primary hyperparathyroidism

postoperative vitamin D supplementation

Additional relevant MeSH terms:

Hyperparathyroidism

Hyperparathyroidism, Primary

Study Results

No Results Posted as of Feb 28, 2019