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Magnesium Nutrition and Sleep Behavior in Older Adults

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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):
USDA Grand Forks Human Nutrition Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Nutritional Deficiency
Insomnia
Interventions Dietary Supplement: Sugar Pill
Dietary Supplement: magnesium
Enrollment 111
Recruitment Details Participants were recruited in 2007 and 2008 by the USDA Grand Forks Human Nutrition Research Center staff in North Dakota.
Pre-assignment Details 425 applications were received. 215 people did not meet the eligibility criteria. 99 people withdrew their application. 111 people were assigned to groups.
Arm/Group Title Sugar Pill Magnesium
Hide Arm/Group Description zero magnesium supplementation 300 milligrams of magnesium daily
Period Title: Overall Study
Started 54 57
Completed 50 50
Not Completed 4 7
Reason Not Completed
Withdrawal by Subject             2             3
Protocol Violation             2             1
Diarrhea             0             2
constipation             0             1
Arm/Group Title Sugar Pill Magnesium Total
Hide Arm/Group Description zero magnesium supplementation 300 milligrams of magnesium daily Total of all reporting groups
Overall Number of Baseline Participants 54 57 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 57 participants 111 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
  74.1%
49
  86.0%
89
  80.2%
>=65 years
14
  25.9%
8
  14.0%
22
  19.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 57 participants 111 participants
60.4  (8.7) 58.2  (6.2) 59.3  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 57 participants 111 participants
Female
39
  72.2%
43
  75.4%
82
  73.9%
Male
15
  27.8%
14
  24.6%
29
  26.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants 57 participants 111 participants
54 57 111
1.Primary Outcome
Title Global Pittsburgh Sleep Quality Index
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sugar Pill Magnesium
Hide Arm/Group Description:
zero magnesium supplementation
300 milligrams of magnesium daily
Overall Number of Participants Analyzed 47 49
Mean (Standard Error)
Unit of Measure: score on a scale
6.30  (0.37) 6.96  (0.36)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugar Pill Magnesium
Hide Arm/Group Description zero magnesium supplementation 300 milligrams of magnesium daily
All-Cause Mortality
Sugar Pill Magnesium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Pill Magnesium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/57 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sugar Pill Magnesium
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/57 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Forrest H Nielsen, PhD
Organization: USDA Grand Forks Human Nutrition ResearchCenter
Phone: 701-790-8455
Responsible Party: USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00833092     History of Changes
Other Study ID Numbers: GFHNRC014
First Submitted: January 27, 2009
First Posted: January 30, 2009
Results First Submitted: July 27, 2011
Results First Posted: April 4, 2012
Last Update Posted: March 26, 2015