NCT01971424

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

1.2 years

First QC Date

October 23, 2013

Last Update Submit

October 23, 2013

Conditions

Keywords

magnesiumSPPBstrengthphysical performance24 hour magnesuria

Outcome Measures

Primary Outcomes (1)

  • Changes in short physical performance battery (SPPB)

    Baseline and after 12 weeks

Secondary Outcomes (1)

  • Changes in appendicular skeletal mass (ASMMI)

    Baseline and after 12 weeks

Study Arms (2)

Mg oxide

EXPERIMENTAL

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

Dietary Supplement: Mg oxideOther: healthy diet

Controls

NO INTERVENTION

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

Interventions

Mg oxideDIETARY_SUPPLEMENT
Also known as: Magnesium oxide
Mg oxide
Mg oxide

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • previous supplementation of calcium, potassium or magnesium
  • use of pump proton inhibitors or digitalis
  • important co-mordidities such renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatrics Division, Department of Medicine

Padua, Padova, 35128, Italy

Location

Related Publications (2)

  • 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.

    PMID: 16895893BACKGROUND
  • Veronese 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.

MeSH Terms

Interventions

Magnesium OxideDiet, Healthy

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsOxidesOxygen CompoundsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 29, 2013

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations