Vitamin D Supplementation After Parathyroid Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism

Conditions
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Primary Hyperparathyroidism

Intervention / Treatment
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* Drug: cholecalciferol and calcium carbonate
* Drug: calcium carbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary hyperparathyroidism subjected to parathyroid surgery Exclusion Criteria: Renal insufficiency Severe osteoporosis Pregnancy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cholecalciferol and calcium carbonate<br>cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2 | Drug: calcium carbonate<br>* calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery<br>* Other names: cholecalciferol and calcium carbonate;|
| Active Comparator: calciumcarbonate<br>calcium carbonate 500 mg x 2 | Drug: cholecalciferol and calcium carbonate<br>* cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery<br>* Other names: calcium carbonate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative parathyroid hormone level | PTH | 3 months | 
| ambulatory blood pressure | 24h blood pressure | one year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary hyperparathyroidism, postoperative vitamin D supplementation