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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giuseppe Sergi, University of Padova
ClinicalTrials.gov Identifier:
NCT01971424
First received: October 23, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • Changes in short physical performance battery (SPPB) [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in appendicular skeletal mass (ASMMI) [ Time Frame: Baseline and after 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01971424

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

Publications:
Responsible Party: Giuseppe Sergi, Medical Doctor, University of Padova
ClinicalTrials.gov Identifier: NCT01971424     History of Changes
Other Study ID Numbers: 2011491
Study First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: Italy: National Bioethics Committee

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

Additional relevant MeSH terms:
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014