Magnesium Nutrition and Sleep Behavior in Older Adults

NCT ID: NCT00833092

Last Updated: 2015-03-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nutritional Deficiency Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sugar pill

Sugar Pill

Group Type PLACEBO_COMPARATOR

Sugar Pill

Intervention Type DIETARY_SUPPLEMENT

Sugar pill supplementation for 9 weeks

magnesium

300 milligrams of magnesium daily

Group Type ACTIVE_COMPARATOR

magnesium

Intervention Type DIETARY_SUPPLEMENT

300 milligrams daily for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sugar Pill

Sugar pill supplementation for 9 weeks

Intervention Type DIETARY_SUPPLEMENT

magnesium

300 milligrams daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

51 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Forrest H Nielsen, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

USDA Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 7481413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17023712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12949381 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GFHNRC014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sleep Timing and Energy Balance
NCT01866280 COMPLETED NA
Aging, Sleep, Cognitive Process
NCT00804804 COMPLETED NA
Aging Program Project Grant 6
NCT03490825 COMPLETED NA
Sleep Extension and Blood Pressure
NCT02929810 COMPLETED NA
Auricular Acupuncture for Sleep Disturbances
NCT04956341 ACTIVE_NOT_RECRUITING NA
Chronic Sleep Restriction
NCT01493661 COMPLETED