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Assessment of Physical Performance After Oral Supplementation of Magnesium in a Sample of Old Women in Good Health (Magnesium)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01971424
First Posted: October 29, 2013
Last Update Posted: October 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Giuseppe Sergi, University of Padova
  Purpose
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

Condition Intervention
Age Related Muscle Loss Dietary Supplement: Mg oxide Other: healthy diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Giuseppe Sergi, University of Padova:

Primary Outcome Measures:
  • Changes in short physical performance battery (SPPB) [ Time Frame: Baseline and after 12 weeks ]

Secondary Outcome Measures:
  • Changes in appendicular skeletal mass (ASMMI) [ Time Frame: Baseline and after 12 weeks ]

Enrollment: 100
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mg oxide
Participants were supplemented for 12-weeks with 300 mg of daily oral magnesium oxide.
Dietary Supplement: Mg oxide
Other Name: Magnesium oxide
Other: healthy diet
No Intervention: Controls
The control group was educated by a trained dietician to follow a healthy diet.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • People over 65 years, not residents in nursing home, in good health

Exclusion Criteria:

  • previous supplementation of calcium, potassium or magnesium
  • use of pump proton inhibitors or digitalis
  • important co-mordidities such renal failure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971424


Locations
Italy
Geriatrics Division, Department of Medicine
Padova, Italy, 35128
Sponsors and Collaborators
University of Padova
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giuseppe Sergi, Medical Doctor, University of Padova
ClinicalTrials.gov Identifier: NCT01971424     History of Changes
Other Study ID Numbers: 2011491
First Submitted: October 23, 2013
First Posted: October 29, 2013
Last Update Posted: October 29, 2013
Last Verified: October 2013

Keywords provided by Giuseppe Sergi, University of Padova:
magnesium
SPPB
strength
physical performance
24 hour magnesuria

Additional relevant MeSH terms:
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents