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Magnesium Nutrition and Sleep Behavior in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00833092
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : April 4, 2012
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Nutritional Deficiency Insomnia Dietary Supplement: Sugar Pill Dietary Supplement: magnesium

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Magnesium Nutrition and Sleep Behavior in Older Adults
Study Start Date : January 2008
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Sugar pill
Sugar Pill
Dietary Supplement: Sugar Pill
Sugar pill supplementation for 9 weeks
Active Comparator: magnesium
300 milligrams of magnesium daily
Dietary Supplement: magnesium
300 milligrams daily for 8 weeks


Outcome Measures

Primary Outcome Measures :
  1. Global Pittsburgh Sleep Quality Index [ Time Frame: 9 weeks ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00833092     History of Changes
Other Study ID Numbers: GFHNRC014
First Posted: January 30, 2009    Key Record Dates
Results First Posted: April 4, 2012
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
magnesium
Nutritional Requirements
Sleep

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders