Trial Outcomes & Findings for Magnesium Nutrition and Sleep Behavior in Older Adults (NCT NCT00833092)

Last Updated: 2015-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

111 participants

Primary outcome timeframe

9 weeks

Results posted on

2015-03-26

Participant Flow

Participants were recruited in 2007 and 2008 by the USDA Grand Forks Human Nutrition Research Center staff in North Dakota.

425 applications were received. 215 people did not meet the eligibility criteria. 99 people withdrew their application. 111 people were assigned to groups.

Participant milestones

Participant milestones
Measure	Sugar Pill zero magnesium supplementation	Magnesium 300 milligrams of magnesium daily
Overall Study STARTED	54	57
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Sugar Pill zero magnesium supplementation	Magnesium 300 milligrams of magnesium daily
Overall Study Withdrawal by Subject	2	3
Overall Study Protocol Violation	2	1
Overall Study Diarrhea	0	2
Overall Study constipation	0	1

Baseline Characteristics

Magnesium Nutrition and Sleep Behavior in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Pill n=54 Participants zero magnesium supplementation	Magnesium n=57 Participants 300 milligrams of magnesium daily	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=93 Participants	49 Participants n=4 Participants	89 Participants n=27 Participants
Age, Categorical >=65 years	14 Participants n=93 Participants	8 Participants n=4 Participants	22 Participants n=27 Participants
Age, Continuous	60.4 years STANDARD_DEVIATION 8.7 • n=93 Participants	58.2 years STANDARD_DEVIATION 6.2 • n=4 Participants	59.3 years STANDARD_DEVIATION 7.5 • n=27 Participants
Sex: Female, Male Female	39 Participants n=93 Participants	43 Participants n=4 Participants	82 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants
Region of Enrollment United States	54 participants n=93 Participants	57 participants n=4 Participants	111 participants n=27 Participants

PRIMARY outcome

Timeframe: 9 weeks

Population: Data from 4 participants (3 on sugar pill, 1 on magnesium) were omitted from statistical analysis because of protocol violations discovered near end of study.

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.

Outcome measures

Outcome measures
Measure	Sugar Pill n=47 Participants zero magnesium supplementation	Magnesium n=49 Participants 300 milligrams of magnesium daily
Global Pittsburgh Sleep Quality Index	6.30 score on a scale Standard Error 0.37	6.96 score on a scale Standard Error 0.36

Adverse Events

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Magnesium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Forrest H Nielsen, PhD

USDA Grand Forks Human Nutrition ResearchCenter

Phone: 701-790-8455

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place