Magnesium Nutrition and Sleep Behavior in Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LuAnn Johnson, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00833092
First received: January 27, 2009
Last updated: April 4, 2012
Last verified: April 2012

January 27, 2009
April 4, 2012
January 2008
December 2008   (final data collection date for primary outcome measure)
Global Pittsburgh Sleep Quality Index [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
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.
Determine the efficacy of magnesium supplementation to improve sleep [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00833092 on ClinicalTrials.gov Archive Site
Not Provided
Determine the association between magnesium nutrition and sleep behavior [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Magnesium Nutrition and Sleep Behavior in Older Adults
Magnesium Nutrition and Sleep Behavior in Older Adults

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Nutritional Deficiency
  • Insomnia
  • Dietary Supplement: Sugar Pill
    Sugar pill supplementation for 9 weeks
  • Dietary Supplement: magnesium
    300 milligrams daily for 8 weeks
  • Placebo Comparator: Sugar pill
    Sugar Pill
    Intervention: Dietary Supplement: Sugar Pill
  • Active Comparator: magnesium
    300 milligrams of magnesium daily
    Intervention: Dietary Supplement: magnesium

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
51 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833092
GFHNRC014
No
LuAnn Johnson, USDA Grand Forks Human Nutrition Research Center
USDA Grand Forks Human Nutrition Research Center
Not Provided
Principal Investigator: Forrest H Nielsen, PhD USDA Grand Forks Human Nutrition Research Center
USDA Grand Forks Human Nutrition Research Center
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP