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Vitamin D Supplementation After Parathyroid Surgery

Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00982722
Enrollment
150
Registered
2009-09-23
Start date
2008-04-30
Completion date
2018-05-04
Last updated
2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hyperparathyroidism

Keywords

primary hyperparathyroidism, postoperative vitamin D supplementation

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).

Interventions

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

DRUGcalcium carbonate

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

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion criteria

* Renal insufficiency * Severe osteoporosis * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
postoperative parathyroid hormone level3 monthsPTH
ambulatory blood pressureone year24h blood pressure

Secondary

MeasureTime frameDescription
25-OH Vitamin D3 monthss-25OHD
Calcium6 weeksionized calcium
Quality of life-self estimating formulariesone yearSF36
bone mineral densityone yearDEXA

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026