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Magnesium Nutrition and Sleep Behavior in Older Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833092
First Posted: January 30, 2009
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
USDA Grand Forks Human Nutrition Research Center
Results First Submitted: July 27, 2011  
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

  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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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 
Overall Participants Analyzed 
[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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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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
e-mail: forrest.nielsen@ars.usda.gov


Publications:

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