Magnesium Nutrition and Sleep Behavior in Older Adults
1 other identifier
interventional
111
1 country
1
Brief Summary
Insomnia is not a natural part of aging but is higher in older adults because of a variety of factors common in later life. One of these factors may be a deficient magnesium status. This study will look at whether or not magnesium supplementation will improve sleep.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2008
1 active site
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, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 27, 2009
CompletedFirst Posted
Study publicly available on registry
January 30, 2009
CompletedResults Posted
Study results publicly available
April 4, 2012
CompletedMarch 26, 2015
March 1, 2015
11 months
January 27, 2009
July 27, 2011
March 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global Pittsburgh Sleep Quality Index
Improvement in the Pittsburgh Global Sleep Quality Index (PGQI). The index is based on a score of 0 to 21, the lower the score on the index the better the subject perceives their sleep.
9 weeks
Study Arms (2)
Sugar pill
PLACEBO COMPARATORSugar Pill
magnesium
ACTIVE COMPARATOR300 milligrams of magnesium daily
Interventions
Eligibility Criteria
You may qualify if:
- have sleep complaints
- Score greater than 5 on Pittsburgh Global Sleep Quality Index
You may not qualify if:
- taking medications that affect sleep
- taking 100 milligrams or more of magnesium
- body mass index of 40 or higher
- abnormal breathing conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58202, United States
Related Publications (3)
Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425.
PMID: 7481413BACKGROUNDHunt CD, Johnson LK. Magnesium requirements: new estimations for men and women by cross-sectional statistical analyses of metabolic magnesium balance data. Am J Clin Nutr. 2006 Oct;84(4):843-52. doi: 10.1093/ajcn/84.4.843.
PMID: 17023712BACKGROUNDFord ES, Mokdad AH. Dietary magnesium intake in a national sample of US adults. J Nutr. 2003 Sep;133(9):2879-82. doi: 10.1093/jn/133.9.2879.
PMID: 12949381BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Forrest H Nielsen, PhD
- Organization
- USDA Grand Forks Human Nutrition ResearchCenter
Study Officials
- PRINCIPAL INVESTIGATOR
Forrest H Nielsen, PhD
USDA Grand Forks Human Nutrition Research Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2009
First Posted
January 30, 2009
Study Start
January 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
March 26, 2015
Results First Posted
April 4, 2012
Record last verified: 2015-03