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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014