Age Related Muscle LossMagnesiumNCT01971424
Assessment of Physical Performance After Oral Supplementation of Magnesium in a Sample of Old Women in Good Health
A study testing Mg oxide and healthy diet in people with Age Related Muscle Loss, run by University of Padova at 1 site in Italy.
Trial summary
Magnesium deficiency is associated also in the elderly with low physical performance; nevertheless trials about the effect of supplementation of magnesium on physical performance are not available in old people. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Age Related Muscle Loss
- What is being tested?
- Mg oxide and healthy diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Mar 2013
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- People over 65 years, not residents in nursing home, in good health
Who cannot join
- previous supplementation of calcium, potassium or magnesium
- use of pump proton inhibitors or digitalis
- important co-mordidities such renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Magnesium deficiency is associated also in the elderly with low physical performance; nevertheless trials about the effect of supplementation of magnesium on physical performance are not available in old people. The aim of our study is to investigate whether 12-weeks of oral magnesium supplementation improves physical performance in healthy elderly women
- Conditions
- Age Related Muscle Loss
- Being tested
- Mg oxide, healthy diet
- Keywords
- magnesium, SPPB, strength, physical performance, 24 hour magnesuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mg oxideDietary supplement
Also called Magnesium oxide
healthy dietOther
| Study group | Role | What they receive |
|---|---|---|
| Mg oxide | Experimental | Participants were supplemented for 12-weeks with 300 mg of daily oral magnesium oxide. Receives: Dietary Supplement: Mg oxide; Other: healthy diet |
| Controls | No intervention | The control group was educated by a trained dietician to follow a healthy diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in short physical performance battery (SPPB)
Measured: Baseline and after 12 weeks
Secondary outcomes (1)
Changes in appendicular skeletal mass (ASMMI)
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age Related Muscle LossStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sergi, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971424
- Sponsor's protocol ID
- 2011491
- Acronym
- Magnesium
- Status last verified
- Oct 2013
- First submitted
- 23 Oct 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dominguez LJ, Barbagallo M, Lauretani F, Bandinelli S, Bos A, Corsi AM, Simonsick EM, Ferrucci L. Magnesium and muscle performance in older persons: the InCHIANTI study. Am J Clin Nutr. 2006 Aug;84(2):419-26. doi: 10.1093/ajcn/84.1.419.
PubMed 16895893Veronese N, Berton L, Carraro S, Bolzetta F, De Rui M, Perissinotto E, Toffanello ED, Bano G, Pizzato S, Miotto F, Coin A, Manzato E, Sergi G. Effect of oral magnesium supplementation on physical performance in healthy elderly women involved in a weekly exercise program: a randomized controlled trial. Am J Clin Nutr. 2014 Sep;100(3):974-81. doi: 10.3945/ajcn.113.080168. Epub 2014 Jul 9.
PubMed 25008857
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical Performance After Oral Supplementation of Magnesium in a Sample of Old Women in Good Health
- ClinicalTrials.gov ID
- NCT01971424
- Acronym / sponsor ID
- Magnesium / 2011491
- Conditions
- Age Related Muscle Loss
- Keywords
- magnesium, SPPB, strength, physical performance, 24 hour magnesuria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Oct 2013 (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.
Magnesium deficiency is associated also in the elderly with low physical performance; nevertheless trials about the effect of supplementation of magnesium on physical performance are not available in old people. The aim of our study is to investigate whether 12-weeks of oral magnesium supplementation improves physical performance in healthy elderly women
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mg oxide | Experimental | Dietary Supplement: Mg oxide, Other: healthy dietParticipants were supplemented for 12-weeks with 300 mg of daily oral magnesium oxide. |
| Controls | No intervention | –The control group was educated by a trained dietician to follow a healthy diet. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- People over 65 years, not residents in nursing home, in good health
Key exclusion criteria (3 listed)
- previous supplementation of calcium, potassium or magnesium
- use of pump proton inhibitors or digitalis
- important co-mordidities such renal failure
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 |
|---|---|---|
| Mg oxideAlso: Magnesium oxide | Dietary supplement | Mg oxide |
| healthy diet | Other | Mg oxide |
Primary outcome
Changes in short physical performance battery (SPPB)
Time frame: Baseline and after 12 weeks
1 secondary outcome
Changes in appendicular skeletal mass (ASMMI)
Time frame: Baseline and after 12 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 Oct 2013.
- Background: PubMed 16895893Dominguez LJ, Barbagallo M, Lauretani F, Bandinelli S, Bos A, Corsi AM, Simonsick EM, Ferrucci L. Magnesium and muscle performance in older persons: the InCHIANTI study. Am J Clin Nutr. 2006 Aug;84(2):419-26. doi: 10.1093/ajcn/84.1.419.
- Derived from this study: PubMed 25008857Veronese N, Berton L, Carraro S, Bolzetta F, De Rui M, Perissinotto E, Toffanello ED, Bano G, Pizzato S, Miotto F, Coin A, Manzato E, Sergi G. Effect of oral magnesium supplementation on physical performance in healthy elderly women involved in a weekly exercise program: a randomized controlled trial. Am J Clin Nutr. 2014 Sep;100(3):974-81. doi: 10.3945/ajcn.113.080168. Epub 2014 Jul 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mg oxide and healthy diet in people with Age Related Muscle Loss, run by University of Padova at 1 site in Italy.
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 3 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 Oct 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 Italy. 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?
Changes in short physical performance battery (SPPB) (time frame: Baseline and after 12 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 NCT01971424, which also lists 2 linked publications.
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 Oct 2013.