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Effect of Vitamin D Treatment in Primary Hyperparathyroidism

NCT ID: NCT00674154

Last Updated: 2013-11-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vitamin D Deficiency Primary Hyperparathyroidism Hypercalcemia

Keywords

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Vitamin D Primary hyperparathyroidism hypercalcemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D group

Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

2800 IE daily in 52 weeks

Placebo group

Placebo, two tablets daily in 52 weeks.

Group Type PLACEBO_COMPARATOR

Cholecalciferol

Intervention Type DRUG

2800 IE daily in 52 weeks

Interventions

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Cholecalciferol

2800 IE daily in 52 weeks

Intervention Type DRUG

Other Intervention Names

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vitamin D

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Rolighed, MD

Role: PRINCIPAL_INVESTIGATOR

Lars Rejnmark, MD,PhD,DrMed

Role: STUDY_DIRECTOR

Locations

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Osteoporoseklinikken, Aarhus University Hospital, THG

Aarhus C, , Denmark

Site Status

Countries

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Denmark

References

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Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.

Reference Type DERIVED
PMID: 35018442 (View on PubMed)

Other Identifiers

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PHPT-20080011

Identifier Type: -

Identifier Source: org_study_id