Back to resultsMagnesium Nutrition and Sleep Behavior in Older Adults
Primary Purpose
Nutritional Deficiency, Insomnia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sugar Pill
magnesium
Sponsored by
About this trial
This is an interventional treatment trial for Nutritional Deficiency focused on measuring magnesium, Nutritional Requirements, Sleep
Eligibility Criteria
Inclusion Criteria:
- have sleep complaints
- Score greater than 5 on Pittsburgh Global Sleep Quality Index
Exclusion Criteria:
- taking medications that affect sleep
- taking 100 milligrams or more of magnesium
- body mass index of 40 or higher
- abnormal breathing conditions
Sites / Locations
- USDA Grand Forks Human Nutrition Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Sugar pill
magnesium
Arm Description
Sugar Pill
300 milligrams of magnesium daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00833092
First Posted
January 27, 2009
Last Updated
March 6, 2015
Sponsor
USDA Grand Forks Human Nutrition Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00833092
Brief Title
Magnesium Nutrition and Sleep Behavior in Older Adults
Official Title
Magnesium Nutrition and Sleep Behavior in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Insomnia affects approximately one-third of older Americans. More than half of all people aged 65 and older experience sleep problems. The prevalence of insomnia and other sleep disorders is not a natural part of aging but is high in older adults because of a variety of factors common in late life. One of those factors may be a deficient magnesium status. There is a close association between sleep architecture, especially slow wave sleep, and activity in the glutamatergic and gamma-aminobutyric acid (GABA) system. Because magnesium is a natural N-methyl-D-aspartate (NMDA)antagonist and GABA agonist, magnesium apparently plays a key role in the regulation of sleep. Such a role is supported by supplementation, correlation, and animal studies showing that magnesium intake or status affects sleep organization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Deficiency, Insomnia
Keywords
magnesium, Nutritional Requirements, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Sugar Pill
Arm Title
magnesium
Arm Type
Active Comparator
Arm Description
300 milligrams of magnesium daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugar Pill
Intervention Description
Sugar pill supplementation for 9 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
magnesium
Intervention Description
300 milligrams daily for 8 weeks
Primary Outcome Measure Information:
Title
Global Pittsburgh Sleep Quality Index
Description
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.
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
have sleep complaints
Score greater than 5 on Pittsburgh Global Sleep Quality Index
Exclusion Criteria:
taking medications that affect sleep
taking 100 milligrams or more of magnesium
body mass index of 40 or higher
abnormal breathing conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Forrest H Nielsen, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7481413
Citation
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.
Results Reference
background
PubMed Identifier
17023712
Citation
Hunt 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.
Results Reference
background
PubMed Identifier
12949381
Citation
Ford 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.
Results Reference
background
Learn more about this trial
Magnesium Nutrition and Sleep Behavior in Older Adults
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