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Completed

NCT Number: NCT00674154

Effect of Vitamin D Treatment in Primary Hyperparathyroidism

The primary aim of the study is to assess whether 6-months of vitamin D supplements can decrease PTH compared with placebo treatment in primary hyperparathyroidism.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Calcium Metabolism Disorders Deficiency Diseases Endocrine System Diseases Hypercalcemia Hyperparathyroidism Hyperparathyroidism, Primary Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Primary Hyperparathyroidism Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Osteoporoseklinikken, Aarhus University Hospital, THG

Aarhus C, 8000, Denmark

About this study

The study investigates effects and safety of six months of vitamin D supplementation before and after surgery in primary hyperparathyroidism. Effects are assessed as changes in calcium homeostasis, bone metabolism, quality of life, and muscle strength and function.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • P-Ca-ion > 1,30 mmol/l
  • P-PTH > 5 pmol/l
  • P-OH25-vitamin D < 80 nmol/l

Exclusion criteria

  • P-creatinin > 120 mumol/l
  • usage of Etalpha, Mimpara
  • Cancer
  • Sarcoidosis
  • malabsorption
  • pancreatitis
  • alcohol abuse
  • pregnancy

Treatment and study plan

Cholecalciferol

Drug

2800 IE daily in 52 weeks

Other names: vitamin D

Primary outcomes

  1. Decrease in Preoperative P-PTH

    Time frame: 25 weeks

    Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.

Secondary outcomes

  1. Improved Muscular Function

    Time frame: One Year

  2. Reduced Postoperative Hypocalcemia

    Time frame: Postoperative week

  3. Increase in Quality of Life

    Time frame: One year

  4. Increased Bone Mineral Density

    Time frame: One year

  5. Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 7, 2008
Registry last updated
Nov 18, 2013

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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