Vitamin D DeficiencyPhase 2/3NCT00674154
Effect of Vitamin D Treatment in Primary Hyperparathyroidism
A Phase 2/3 study testing Cholecalciferol in people with Vitamin D Deficiency and Primary Hyperparathyroidism, run by University of Aarhus at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Primary Hyperparathyroidism, Hypercalcemia
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- May 2008to Aug 2013
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- P-Ca-ion > 1,30 mmol/l
- P-PTH > 5 pmol/l
- P-OH25-vitamin D < 80 nmol/l
Who cannot join
- P-creatinin > 120 mumol/l
- usage of Etalpha, Mimpara
- Cancer
- Sarcoidosis
- malabsorption
- pancreatitis
- alcohol abuse
- pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Osteoporoseklinikken, Aarhus University Hospital, THG
Aarhus C, 8000
About this study
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.
Read the detailed 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.
- Being tested
- Cholecalciferol
- Keywords
- Vitamin D, Primary hyperparathyroidism, hypercalcemia
- Medical subject headings
- Vitamin D Deficiency, Hyperparathyroidism, Primary, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called vitamin D
2800 IE daily in 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | Cholecalciferol 1400 IU, 2 tablets once daily in 52 weeks Receives: Drug: Cholecalciferol |
| Placebo group | Placebo comparator | Placebo, two tablets daily in 52 weeks. Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Preoperative P-PTH
Decrease in plasma PTH after 25 weeks of preoperative vitamin D treatment compared with the plasebo Group.
Measured: 25 weeks
Secondary outcomes (5)
Improved Muscular Function
Measured: One Year
Reduced Postoperative Hypocalcemia
Measured: Postoperative week
Increase in Quality of Life
Measured: One year
Increased Bone Mineral Density
Measured: One year
Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Rolighed, MD, Principal investigatorLars Rejnmark, MD,PhD,DrMed, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674154
- Sponsor's protocol ID
- PHPT-20080011
- Status last verified
- Aug 2013
- First submitted
- 5 May 2008
- Last updated
- 18 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 35018442
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Treatment in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT00674154
- Acronym / sponsor ID
- PHPT-20080011
- Keywords
- Vitamin D, Primary hyperparathyroidism, hypercalcemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 16 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Drug: CholecalciferolCholecalciferol 1400 IU, 2 tablets once daily in 52 weeks |
| Placebo group | Placebo comparator | Drug: CholecalciferolPlacebo, two tablets daily in 52 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- P-Ca-ion > 1,30 mmol/l
- P-PTH > 5 pmol/l
- P-OH25-vitamin D < 80 nmol/l
Key exclusion criteria (8 listed)
- P-creatinin > 120 mumol/l
- usage of Etalpha, Mimpara
- Cancer
- Sarcoidosis
- malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: vitamin D2800 IE daily in 52 weeks | Drug | Placebo group, Vitamin D group |
Primary outcome
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.
5 secondary outcomes
Improved Muscular Function
Time frame: One Year
Reduced Postoperative Hypocalcemia
Time frame: Postoperative week
Increase in Quality of Life
Time frame: One year
Increased Bone Mineral Density
Time frame: One year
Increase in Trabecular and Cortical vBMD Measured by QCT and pQCT of Hip, Spine and Forearm
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35018442Bislev 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Rolighed, MD principal investigator
Lars Rejnmark, MD,PhD,DrMed study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cholecalciferol in people with Vitamin D Deficiency and Primary Hyperparathyroidism, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Preoperative P-PTH (time frame: 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00674154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2013.