An interventional study of Sugar Pill and magnesium in Nutritional Deficiency and Insomnia, sponsored by USDA Grand Forks Human Nutrition Research Center. Completed at 1 site in United States. Open to participants aged 51 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-26.
Sponsored by USDA Grand Forks Human Nutrition Research Center · Not applicable, Interventional, and Treatment
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 111 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →USDA Grand Forks Human Nutrition Research Center is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sugar Pill
Dietary Supplement: Sugar Pill
300 milligrams of magnesium daily
Dietary Supplement: magnesium
Sugar pill supplementation for 9 weeks
300 milligrams daily for 8 weeks
Global Pittsburgh Sleep Quality Index
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.
Time frame: 9 weeks
Participants were recruited in 2007 and 2008 by the USDA Grand Forks Human Nutrition Research Center staff in North Dakota.
| Milestone | Sugar Pill | Magnesium |
|---|---|---|
| Started | 54 | 57 |
| Completed | 50 | 50 |
| Not completed | 4 | 7 |
| Withdrew: Withdrawal by subject | 2 | 3 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Diarrhea | 0 | 2 |
| Withdrew: Constipation | 0 | 1 |
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.
| score on a scale | Sugar Pill | Magnesium |
|---|---|---|
| Global Pittsburgh Sleep Quality Index | 6.30 ± 0.37 | 6.96 ± 0.36 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sugar Pill | — | 0/54 (0%) | 0/54 (0%) |
| Magnesium | — | 0/57 (0%) | 0/57 (0%) |
| Age, Categorical(Participants) | Sugar Pill | Magnesium | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 49 | 89 |
| >=65 years | 14 | 8 | 22 |
| Age, Continuous(years) | Sugar Pill | Magnesium | Total |
|---|---|---|---|
| Mean | 60.4 ± 8.7 | 58.2 ± 6.2 | 59.3 ± 7.5 |
| Sex: Female, Male(Participants) | Sugar Pill | Magnesium | Total |
|---|---|---|---|
| Female | 39 | 43 | 82 |
| Male | 15 | 14 | 29 |
| Region of Enrollment(participants) | Sugar Pill | Magnesium | Total |
|---|---|---|---|
| United States | 54 | 57 | 111 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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USDA Grand Forks Human Nutrition Research Center