Magnesium DeficiencyPhase 4NCT01593501
How Does Magnesium Status Influence Calcium Homeostasis?
A Phase 4 study testing vitamin D3 in people with Magnesium Deficiency and Calcium Metabolism Disorders, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The investigators aim to recruit 60 women who have agreed to participate in an existing randomized, double-blind, placebo-controlled trial (Treatment of Vitamin D Insufficiency, HSC 2009-0055). Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Magnesium Deficiency, Calcium Metabolism Disorders
- What is being tested?
- vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2014
- Phase
- Phase 4
- 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 30 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants eligible for the study "Treatment of vitamin D insufficiency" are eligible for participation in the current sub-study
Who cannot join
- identical to those covered in HSC #2009-0055
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison Hospital, Clinical Research Unit, Osteoporosis Research Center
Madison, Wisconsin, 53705
About this study
The investigators aim to recruit 60 women who have agreed to participate in an existing randomized, double-blind, placebo-controlled trial (Treatment of Vitamin D Insufficiency, HSC 2009-0055). In this trial, the investigators propose to evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis. The investigators will stratify 60 subjects in the sub-study, ensuring that approximately 20 subjects are randomized into each treatment arm (placebo, low-dose and high-dose vitamin D). The investigators already assess calcium homeostasis throughout the study by measuring bone mineral density, fractional calcium absorption, serum and urine calcium levels, among other tests. In the sub-study of 60 women, the investigators will evaluate whether habitually higher magnesium intake increases or decreases fractional calcium absorption. The investigators will evaluate the interplay between magnesium stores, vitamin D levels and serum parathyroid hormone levels. The investigators will directly assess magnesium stores using serum magnesium and 24-hour urine magnesium levels, and will measure magnesium absorption using the dual stable isotope approach.
Read the detailed description
Use of serum magnesium isotopes to measure fractional magnesium absorption Four day food diaries to assess magnesium intake Standard urine and serum chemistries for remaining labs as noted above
- Conditions
- Magnesium Deficiency, Calcium Metabolism Disorders
- Being tested
- vitamin D3
- Keywords
- vitamin D, cholecalciferol, bone mineral density, Magnesium deficiency, Calcium metabolism disorders
- Medical subject headings
- Magnesium Deficiency, Calcium Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Dietary supplement
Also called Cholecalciferol
pharmaceutical grade D3
| Study group | Role | What they receive |
|---|---|---|
| High dose vitamin D | Active comparator | 50,000 IU vitamin D3 every 15 days, with a loading dose of 50,000 IU per day for the first 15 days of an approximate 365-day treatment. Receives: Dietary Supplement: vitamin D3 |
| Low dose vitamin D | Active comparator | 800 IU vitamin D3 every day of an approximate 365-day treatment. Receives: Dietary Supplement: vitamin D3 |
| Placebo | Placebo comparator | A pill that looks like the low/high dose vitamin D pills, but contains no vitamin D. Given to preserve the double-blind nature of the study. Receives: Dietary Supplement: vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis.
To evaluate relationships between magnesium intake and fractional magnesium absorption at baseline and 12 months, among 60 women participating in HSC Protocol 2009-0055, and to assess whether vitamin D therapy influences magnesium absorption among these women. We will also evaluate whether data collected from less than 72 hours of urine following tracer administration permits accurate assessment of fractional magnesium absorption.
Measured: 0-12 months
Secondary outcomes (3)
Does vitamin D therapy have a differential impact on calcium absorption that is dependent on magnesium stores?
To assess whether vitamin D therapy has a differential impact on calcium absorption, depending on magnesium stores. We will use data from all subjects participating in HSC Protocol 2009-0055 to evaluate whether magnesium status is a co-factor in the change in calcium absorption that occurs with vitamin D therapy.
Measured: 0-12 months
Assessing relationships between magnesium status and bone mineral density.
Measured: 0-12 months
Evaluate how magnesium status impacts the relationship between vitamin D levels and parathyroid hormone levels.
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnesium DeficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Karen E Hansen, M.D., M.S., Principal investigator, University of Wisconsin-Madison, Department of Medicine, Division of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593501
- Sponsor's protocol ID
- HSC #2011-0547
- Other IDs
- R01AG028739-01A2
- Status last verified
- Oct 2016
- First submitted
- 4 May 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hansen KE, Nabak AC, Johnson RE, Marvdashti S, Keuler NS, Shafer MM, Abrams SA. Isotope concentrations from 24-h urine and 3-h serum samples can be used to measure intestinal magnesium absorption in postmenopausal women. J Nutr. 2014 Apr;144(4):533-7. doi: 10.3945/jn.113.186767. Epub 2014 Feb 5.
PubMed 24500940
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Magnesium Status Influence Calcium Homeostasis?
- ClinicalTrials.gov ID
- NCT01593501
- Acronym / sponsor ID
- HSC #2011-0547
- Conditions
- Magnesium Deficiency, Calcium Metabolism Disorders
- Keywords
- vitamin D, cholecalciferol, bone mineral density, Magnesium deficiency, Calcium metabolism disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 May 2012 (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.
The investigators aim to recruit 60 women who have agreed to participate in an existing randomized, double-blind, placebo-controlled trial (Treatment of Vitamin D Insufficiency, HSC 2009-0055). In this trial, the investigators propose to evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis. The investigators will stratify 60 subjects in the sub-study, ensuring that approximately 20 subjects are randomized into each treatment arm (placebo, low-dose and high-dose vitamin D). The investigators already assess calcium homeostasis throughout the study by measuring bone mineral density, fractional calcium absorption, serum and urine calcium levels, among other tests. In the sub-study of 60 women, the investigators will evaluate whether habitually higher magnesium intake increases or decreases fractional calcium absorption. The investigators will evaluate the interplay between magnesium stores, vitamin D levels and serum parathyroid hormone levels. The investigators will directly assess magnesium stores using serum magnesium and 24-hour urine magnesium levels, and will measure magnesium absorption using the dual stable isotope approach.
Detailed description
Use of serum magnesium isotopes to measure fractional magnesium absorption Four day food diaries to assess magnesium intake Standard urine and serum chemistries for remaining labs as noted above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose vitamin D | Active comparator | Dietary Supplement: vitamin D350,000 IU vitamin D3 every 15 days, with a loading dose of 50,000 IU per day for the first 15 days of an approximate 365-day treatment. |
| Low dose vitamin D | Active comparator | Dietary Supplement: vitamin D3800 IU vitamin D3 every day of an approximate 365-day treatment. |
| Placebo | Placebo comparator | Dietary Supplement: vitamin D3A pill that looks like the low/high dose vitamin D pills, but contains no vitamin D. Given to preserve the double-blind nature of the study. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants eligible for the study "Treatment of vitamin D insufficiency" are eligible for participation in the current sub-study
Key exclusion criteria (1 listed)
- identical to those covered in HSC #2009-0055
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 |
|---|---|---|
| vitamin D3Also: Cholecalciferolpharmaceutical grade D3 | Dietary supplement | High dose vitamin D, Low dose vitamin D, Placebo |
Primary outcome
Evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis.
Time frame: 0-12 months
To evaluate relationships between magnesium intake and fractional magnesium absorption at baseline and 12 months, among 60 women participating in HSC Protocol 2009-0055, and to assess whether vitamin D therapy influences magnesium absorption among these women. We will also evaluate whether data collected from less than 72 hours of urine following tracer administration permits accurate assessment of fractional magnesium absorption.
3 secondary outcomes
Does vitamin D therapy have a differential impact on calcium absorption that is dependent on magnesium stores?
Time frame: 0-12 months
Assessing relationships between magnesium status and bone mineral density.
Time frame: 0-12 months
Evaluate how magnesium status impacts the relationship between vitamin D levels and parathyroid hormone levels.
Time frame: 0-12 months
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 1 Nov 2016.
- Background: PubMed 24500940Hansen KE, Nabak AC, Johnson RE, Marvdashti S, Keuler NS, Shafer MM, Abrams SA. Isotope concentrations from 24-h urine and 3-h serum samples can be used to measure intestinal magnesium absorption in postmenopausal women. J Nutr. 2014 Apr;144(4):533-7. doi: 10.3945/jn.113.186767. Epub 2014 Feb 5.
Related trials for Magnesium Deficiency
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Magnesium in Gastrointestinal Disease
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Hypomagnesemia
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.
Karen E Hansen, M.D., M.S. principal investigator
University of Wisconsin-Madison, Department of Medicine, Division of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vitamin D3 in people with Magnesium Deficiency and Calcium Metabolism Disorders, run by University of Wisconsin, Madison at 1 site in United States.
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 1 inclusion and 1 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 1 Nov 2016. 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 United States. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate the associations between magnesium intake, magnesium stores, fractional magnesium absorption and calcium homeostasis. (time frame: 0-12 months). 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 NCT01593501, 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 1 Nov 2016.