HypoparathyroidismNCT00824226
Magnesium Treatment in Hypoparathyroidism
A study testing magnesium in people with Hypoparathyroidism, run by University of Tartu at 1 site in Estonia.
Trial summary
Study hypothesis: supplementary magnesium may influence the blood calcium level in treated hypoparathyroid patients. Patients will be treated with supplementary magnesium (350 mg/day) for 3 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism
- What is being tested?
- magnesium
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteEstonia
- Study dates
- Jan 2009to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- primary or secondary hypoparathyroidism
- treatment with calcium plus vitamin D analogue
- ionized calcium 1,0-1,29 mmol/L
- magnesium level 0,7-1,05 mmol/L
- TSH 0.1- 10 imU/L
Who cannot join
- any other disease known to influence plasma Ca level
- pregnancy
- creatinine > 150 microM/L
- patient has used supplementary magnesium within 2 previous months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Magnesium Treatment on Plasma Calcium in Hypoparathyroid Patients
Study hypothesis: supplementary magnesium may influence the blood calcium level in treated hypoparathyroid patients. Patients will be treated with supplementary magnesium (350 mg/day) for 3 weeks. Calcium and other relevant blood parameters will be measured before the treatment, at the end of treatment and 2 weeks after stopping treatment.
- Conditions
- Hypoparathyroidism
- Being tested
- magnesium
- Keywords
- primary hypoparathyroidism, secondary hypoparathyroidism, magnesium
- Medical subject headings
- Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesiumDietary supplement
magnesium 350 mg tablets once a day for 3 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium level at the end of magnesium treatment compared to pretreatment level
Measured: 3 weeks
Secondary outcomes (1)
Calcium level after stopping treatment compared to the level at the end of magnesium treatment
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vallo Volke, University of Tartu
- Investigators
- Vallo Volke, MD, PhD, Principal investigator, University of Tartu, Institute of Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824226
- Sponsor's protocol ID
- UT296
- Status last verified
- Aug 2011
- First submitted
- 15 Jan 2009
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Treatment on Plasma Calcium in Hypoparathyroid Patients
- ClinicalTrials.gov ID
- NCT00824226
- Acronym / sponsor ID
- UT296
- Conditions
- Hypoparathyroidism
- Keywords
- primary hypoparathyroidism, secondary hypoparathyroidism, magnesium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study hypothesis: supplementary magnesium may influence the blood calcium level in treated hypoparathyroid patients. Patients will be treated with supplementary magnesium (350 mg/day) for 3 weeks. Calcium and other relevant blood parameters will be measured before the treatment, at the end of treatment and 2 weeks after stopping treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary or secondary hypoparathyroidism
- treatment with calcium plus vitamin D analogue
- ionized calcium 1,0-1,29 mmol/L
- magnesium level 0,7-1,05 mmol/L
- TSH 0.1- 10 imU/L
Key exclusion criteria (4 listed)
- any other disease known to influence plasma Ca level
- pregnancy
- creatinine > 150 microM/L
- patient has used supplementary magnesium within 2 previous months
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 |
|---|---|---|
| magnesiummagnesium 350 mg tablets once a day for 3 weeks | Dietary supplement | – |
Primary outcome
Calcium level at the end of magnesium treatment compared to pretreatment level
Time frame: 3 weeks
1 secondary outcome
Calcium level after stopping treatment compared to the level at the end of magnesium treatment
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
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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.
Vallo Volke, MD, PhD principal investigator
University of Tartu, Institute of Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnesium in people with Hypoparathyroidism, run by University of Tartu at 1 site in Estonia.
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 5 inclusion and 4 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 29 Aug 2011. 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 Estonia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Calcium level at the end of magnesium treatment compared to pretreatment level (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2011.