Vitamin D Supplementation After Parathyroid Surgery

NCT ID: NCT00982722

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2018-05-04

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).

Conditions

Primary Hyperparathyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

cholecalciferol and calcium carbonate

cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2

Group Type: EXPERIMENTAL

calcium carbonate

Intervention Type: DRUG

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

calciumcarbonate

calcium carbonate 500 mg x 2

Group Type: ACTIVE_COMPARATOR

cholecalciferol and calcium carbonate

Intervention Type: DRUG

cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery

Interventions

cholecalciferol and calcium carbonate

cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2 one year after parathyroid adenomectomy, initiated 6 weeks after surgery

Intervention Type: DRUG

calcium carbonate

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

Intervention Type: DRUG

Other Intervention Names

calcium carbonate; cholecalciferol and calcium carbonate

Eligibility Criteria

Inclusion Criteria

• Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion Criteria

• Renal insufficiency
• Severe osteoporosis
• Pregnancy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Inga-Lena Nilsson

Assoc prof, senior consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inga-Lena Nilsson, MD, Ass prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska UH

Locations

Karolinska UH

Stockholm, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: RESULT

PMID: 24115138 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24026893 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25414430 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26435425 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28522130 (View on PubMed)

Other Identifiers

Eudra CT 2007-003691-19

Identifier Type: -

Identifier Source: org_study_id