NCT00982722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

10.1 years

First QC Date

September 22, 2009

Last Update Submit

February 26, 2019

Conditions

Primary Hyperparathyroidism

Keywords

primary hyperparathyroidismpostoperative vitamin D supplementation

Outcome Measures

Primary Outcomes (2)

  • postoperative parathyroid hormone level

    PTH

    3 months

  • ambulatory blood pressure

    24h blood pressure

    one year

Secondary Outcomes (4)

  • bone mineral density

    one year

  • 25-OH Vitamin D

    3 months

  • Calcium

    6 weeks

  • Quality of life-self estimating formularies

    one year

Study Arms (2)

cholecalciferol and calcium carbonate

EXPERIMENTAL

cholecalciferol 800 IUx2 and calcium carbonate 500 mg x 2

Drug: calcium carbonate

calciumcarbonate

ACTIVE COMPARATOR

calcium carbonate 500 mg x 2

Drug: cholecalciferol and calcium carbonate

Interventions

cholecalciferol and calcium carbonateDRUG

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

Also known as: calcium carbonate
calciumcarbonate
calcium carbonateDRUG

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

Also known as: cholecalciferol and calcium carbonate
cholecalciferol and calcium carbonate

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary hyperparathyroidism subjected to parathyroid surgery

You may not qualify if:

  • Renal insufficiency
  • Severe osteoporosis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska UH

Stockholm, 17176, Sweden

Location

Karolinska University Hospital

Stockholm, SE-17176, Sweden

Location

Related Publications (5)

  • Norenstedt S, Pernow Y, Zedenius J, Nordenstrom J, Saaf M, Granath F, Nilsson IL. Vitamin D supplementation after parathyroidectomy: effect on bone mineral density-a randomized double-blind study. J Bone Miner Res. 2014 Apr;29(4):960-7. doi: 10.1002/jbmr.2102.

    PMID: 24115138RESULT

  • Norenstedt S, Pernow Y, Brismar K, Saaf M, Ekip A, Granath F, Zedenius J, Nilsson IL. Primary hyperparathyroidism and metabolic risk factors, impact of parathyroidectomy and vitamin D supplementation, and results of a randomized double-blind study. Eur J Endocrinol. 2013 Oct 21;169(6):795-804. doi: 10.1530/EJE-13-0547. Print 2013 Dec.

    PMID: 24026893RESULT

  • Aberg V, Norenstedt S, Zedenius J, Saaf M, Nordenstrom J, Pernow Y, Nilsson IL. Health-related quality of life after successful surgery for primary hyperparathyroidism: no additive effect from vitamin D supplementation: results of a double-blind randomized study. Eur J Endocrinol. 2015 Feb;172(2):181-7. doi: 10.1530/EJE-14-0757. Epub 2014 Nov 20.

    PMID: 25414430RESULT

  • Nilsson IL, Norenstedt S, Granath F, Zedenius J, Pernow Y, Larsson TE. FGF23, metabolic risk factors, and blood pressure in patients with primary hyperparathyroidism undergoing parathyroid adenomectomy. Surgery. 2016 Jan;159(1):211-7. doi: 10.1016/j.surg.2015.06.057. Epub 2015 Oct 2.

    PMID: 26435425RESULT

  • Nilsson IL, Norenstedt S, Zedenius J, Pernow Y, Branstrom R. Primary hyperparathyroidism, hypercalciuria, and bone recovery after parathyroidectomy. Surgery. 2017 Aug;162(2):429-436. doi: 10.1016/j.surg.2017.02.017. Epub 2017 May 15.

    PMID: 28522130RESULT

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

CholecalciferolCalcium Carbonate

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Inga-Lena Nilsson, MD, Ass prof

    Karolinska UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc prof, senior consultant

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 23, 2009

Study Start

April 1, 2008

Primary Completion

May 4, 2018

Study Completion

May 4, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)