Vitamin D Supplementation After Parathyroid Surgery

Karolinska University Hospital

Status: Completed

Conditions: Primary Hyperparathyroidism

Treatments: Drug: cholecalciferol and calcium carbonate; Drug: calcium carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT00982722

Eudra CT 2007-003691-19

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion criteria

• Renal insufficiency
• Severe osteoporosis
• Pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

cholecalciferol and calcium carbonate

Experimental group

Description:

cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2

Treatment:

Drug: calcium carbonate

calciumcarbonate

Active Comparator group

Description:

calcium carbonate 500 mg x 2

Treatment:

Drug: cholecalciferol and calcium carbonate