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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cholecalciferol and calcium carbonate | Experimental | cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2 |
|
| calciumcarbonate | Active Comparator | calcium carbonate 500 mg x 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol and calcium carbonate | Drug | cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative parathyroid hormone level | PTH | 3 months |
| ambulatory blood pressure | 24h blood pressure | one year |
| Measure | Description | Time Frame |
|---|---|---|
| bone mineral density | DEXA | one year |
| 25-OH Vitamin D | s-25OHD | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inga-Lena Nilsson, MD, Ass prof | Karolinska UH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska UH | Stockholm | 17176 | Sweden | |||
| Karolinska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24115138 | Result | 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. | |
| 24026893 | Result | 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. |
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| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| calcium carbonate | Drug | calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery |
|
|
| Calcium |
ionized calcium |
| 6 weeks |
| Quality of life-self estimating formularies | SF36 | one year |
| Stockholm |
| SE-17176 |
| Sweden |
| 25414430 | Result | 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. |
| 26435425 | Result | 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. |
| 28522130 | Result | 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. |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |