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

Sponsor

University of Padova (Other)

Overall Status

Completed

CT.gov ID

NCT01971424

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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. The aim of our study is to investigate whether 12-weeks of oral magnesium supplementation improves physical performance in healthy elderly women

Condition or Disease	Intervention/Treatment	Phase
Age Related Muscle Loss	Dietary Supplement: Mg oxide Other: healthy diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mg oxide Participants were supplemented for 12-weeks with 300 mg of daily oral magnesium oxide.	Dietary Supplement: Mg oxide Other Names: Magnesium oxide Other: healthy diet
No Intervention: Controls The control group was educated by a trained dietician to follow a healthy diet.

Arm

Intervention/Treatment

Experimental: Mg oxide

Participants were supplemented for 12-weeks with 300 mg of daily oral magnesium oxide.

Dietary Supplement: Mg oxide

Other Names:

Magnesium oxide

Other: healthy diet

No Intervention: Controls

The control group was educated by a trained dietician to follow a healthy diet.

Outcome Measures

Primary Outcome Measures

Changes in short physical performance battery (SPPB) [Baseline and after 12 weeks]

Secondary Outcome Measures

Changes in appendicular skeletal mass (ASMMI) [Baseline and after 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Geriatrics Division, Department of Medicine	Padova		Italy	35128

Sponsors and Collaborators

University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Giuseppe Sergi, Medical Doctor, University of Padova

ClinicalTrials.gov Identifier:

NCT01971424

Other Study ID Numbers:

2011491

First Posted:

Oct 29, 2013

Last Update Posted:

Oct 29, 2013

Last Verified:

Oct 1, 2013

Keywords provided by Giuseppe Sergi, Medical Doctor, University of Padova

Additional relevant MeSH terms:

Magnesium Oxide

Study Results

No Results Posted as of Oct 29, 2013