Magnesium Nutrition and Sleep Behavior in Older Adults - Full Text View

Sponsored by:	USDA Grand Forks Human Nutrition Research Center
Information provided by:	USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:	NCT00833092

Purpose

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 of not magnesium supplementation will improve sleep.

Condition	Intervention
Nutritional Deficiency Insomnia	Dietary Supplement: zero magnesium Dietary Supplement: magnesium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:	Magnesium Nutrition and Sleep Behavior in Older Adults

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Magnesium

U.S. FDA Resources

Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:

Determine the efficacy of magnesium supplementation to improve sleep [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the association between magnesium nutrition and sleep behavior [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Enrollment:	111
Study Start Date:	January 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sugar pill: Placebo Comparator zero magnesium supplementation	Dietary Supplement: zero magnesium zero magnesium supplementation for 9 weeks
magnesium: Active Comparator 300 milligrams of magnesium daily	Dietary Supplement: magnesium 300 milligrams daily for 8 weeks

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)ergic 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.

Eligibility

Ages Eligible for Study:	51 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

have sleep complaints

Exclusion Criteria:

taking medications that affect sleep
taking 100 milligrams or more of magnesium
body mass index of 40 or higher
abnormal breathing conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833092

Locations

United States, North Dakota
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58202

Sponsors and Collaborators

USDA Grand Forks Human Nutrition Research Center

Investigators

Principal Investigator:

Forrest H Nielsen, PhD

USDA Grand Forks Human Nutrition Research Center

More Information

Publications:

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.

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.

Ford ES, Mokdad AH. Dietary magnesium intake in a national sample of US adults. J Nutr. 2003 Sep;133(9):2879-82.

Responsible Party:	USDA Grand Forks Human Nutrition Research Center ( Forrest H Nielsen )
Study ID Numbers:	GFHNRC014
Study First Received:	January 27, 2009
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00833092 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by USDA Grand Forks Human Nutrition Research Center:

magnesium
Nutritional Requirements
Sleep

Study placed in the following topic categories:

Malnutrition
Nutrition Disorders

Additional relevant MeSH terms:

Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 28, 2009