Effect of Vitamin D Treatment in Primary Hyperparathyroidism

University of Aarhus

Status and phase: Completed; Phase 3; Phase 2

Conditions: Primary Hyperparathyroidism; Hypercalcemia; Vitamin D Deficiency

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT00674154

PHPT-20080011

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Vitamin D group

Experimental group

Description:

Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks

Treatment:

Drug: Cholecalciferol

Placebo group

Placebo Comparator group

Description:

Placebo, two tablets daily in 52 weeks.

Treatment:

Drug: Cholecalciferol