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
  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 or not magnesium supplementation will improve sleep.


Condition Intervention
Nutritional Deficiency
Insomnia
Dietary Supplement: Sugar Pill
Dietary Supplement: magnesium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Magnesium Nutrition and Sleep Behavior in Older Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


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
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

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.

  Eligibility

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: LuAnn Johnson, Statistician, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00833092     History of Changes
Other Study ID Numbers: GFHNRC014
Study First Received: January 27, 2009
Results First Received: July 27, 2011
Last Updated: April 4, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Nutrition Disorders
Malnutrition

ClinicalTrials.gov processed this record on October 19, 2014