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Completed

NCT Number: NCT00982722

Vitamin D Supplementation After Parathyroid Surgery

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska UH, Stockholm, Sweden

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary hyperparathyroidism subjected to parathyroid surgery

Exclusion criteria

  • Renal insufficiency
  • Severe osteoporosis
  • Pregnancy

Treatment and study plan

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

Other names: calcium carbonate

Calcium Carbonate

Drug

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

Other names: cholecalciferol and calcium carbonate

Primary outcomes

  1. postoperative parathyroid hormone level

    Time frame: 3 months

    PTH

  2. ambulatory blood pressure

    Time frame: one year

    24h blood pressure

Secondary outcomes

  1. bone mineral density

    Time frame: one year

    DEXA

  2. 25-OH Vitamin D

    Time frame: 3 months

    s-25OHD

  3. Calcium

    Time frame: 6 weeks

    ionized calcium

  4. Quality of life-self estimating formularies

    Time frame: one year

    SF36

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

Vitamin D Supplementation After Successful Parathyroid Surgery for Primary Hyperparathyroidism

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Sep 23, 2009
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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