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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
History of Changes
Results First Received: July 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Nutritional Deficiency
Insomnia
Interventions: Dietary Supplement: Sugar Pill
Dietary Supplement: magnesium

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited in 2007 and 2008 by the USDA Grand Forks Human Nutrition Research Center staff in North Dakota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
425 applications were received. 215 people did not meet the eligibility criteria. 99 people withdrew their application. 111 people were assigned to groups.

Reporting Groups
  Description
Sugar Pill zero magnesium supplementation
Magnesium 300 milligrams of magnesium daily

Participant Flow:   Overall Study
    Sugar Pill     Magnesium  
STARTED     54     57  
COMPLETED     50     50  
NOT COMPLETED     4     7  
Withdrawal by Subject                 2                 3  
Protocol Violation                 2                 1  
Diarrhea                 0                 2  
constipation                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Sugar Pill zero magnesium supplementation
Magnesium 300 milligrams of magnesium daily
Total Total of all reporting groups

Baseline Measures
    Sugar Pill     Magnesium     Total  
Number of Participants  
[units: participants]
 		  54     57     111  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     40     49     89  
>=65 years     14     8     22  
Age  
[units: years]
Mean ± Standard Deviation 		  60.4  ± 8.7     58.2  ± 6.2     59.3  ± 7.5  
Gender  
[units: participants]
 		     
Female     39     43     82  
Male     15     14     29  
Region of Enrollment  
[units: participants]
 		     
United States     54     57     111  



  Outcome Measures

1.  Primary:   Global Pittsburgh Sleep Quality Index   [ Time Frame: 9 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Forrest H Nielsen, PhD
Organization: USDA Grand Forks Human Nutrition ResearchCenter
phone: 701-790-8455
e-mail: forrest.nielsen@ars.usda.gov


Publications:


Responsible Party: LuAnn Johnson, 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