Vitamin D Supplementation After Parathyroid Surgery

Primary Hyperparathyroidism Clinical Trial

Official title:

Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982722
• Other study ID #: Eudra CT 2007-003691-19
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: May 4, 2018

Study information

• Verified date: February 2019
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 4, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion Criteria:

• Renal insufficiency

• Severe osteoporosis

• Pregnancy

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Intervention

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
• calcium carbonate
calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery

Locations

Country	Name	City	State
Sweden	Karolinska UH	Stockholm
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Åberg V, Norenstedt S, Zedenius J, Sääf M, Nordenström 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 randomize — View Citation

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. — View Citation

Nilsson IL, Norenstedt S, Zedenius J, Pernow Y, Bränström 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. — View Citation

Norenstedt S, Pernow Y, Brismar K, Sääf 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 — View Citation

Norenstedt S, Pernow Y, Zedenius J, Nordenström J, Sääf 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative parathyroid hormone level	PTH	3 months
Primary	ambulatory blood pressure	24h blood pressure	one year
Secondary	bone mineral density	DEXA	one year
Secondary	25-OH Vitamin D	s-25OHD	3 months
Secondary	Calcium	ionized calcium	6 weeks
Secondary	Quality of life-self estimating formularies	SF36	one year