Vitamin D Supplementation After Parathyroid Surgery

Not Applicable

Completed

• Conditions: Primary Hyperparathyroidism
• Interventions: Drug: cholecalciferol and calcium carbonate; Drug: calcium carbonate

• Registration Number: NCT00982722
• Lead Sponsor: Karolinska University Hospital

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).

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Primary Completion: 2018-05-04
• Study Completion: 2018-05-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion Criteria

• Renal insufficiency
• Severe osteoporosis
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
calciumcarbonate	cholecalciferol and calcium carbonate	calcium carbonate 500 mg x 2
cholecalciferol and calcium carbonate	calcium carbonate	cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2

Primary Outcome Measures

Name	Time	Method
postoperative parathyroid hormone level	3 months	PTH
ambulatory blood pressure	one year	24h blood pressure

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Karolinska UH; 🇸🇪 Stockholm, Sweden