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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01971424
Other study ID # 2011491
Secondary ID
Status Completed
Phase N/A
First received October 23, 2013
Last updated October 23, 2013
Start date January 2012
Est. completion date March 2013

Study information

Verified date October 2013
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority Italy: National Bioethics Committee
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Mg oxide

Other:
healthy diet


Locations

Country Name City State
Italy Geriatrics Division, Department of Medicine Padova

Sponsors (1)

Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in short physical performance battery (SPPB) Baseline and after 12 weeks No
Secondary Changes in appendicular skeletal mass (ASMMI) Baseline and after 12 weeks No
See also
  Status Clinical Trial Phase
Completed NCT02118181 - Assessment of Physical Performance With A Supplementation Containing HMB in a Sample of Old Women in Good Health N/A