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Vitamin D and Mortality: an Individual Participant Data Meta-analysis of Standardized 25-hydroxyvitamin D

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.
 
ClinicalTrials.gov Identifier: NCT02438488
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : November 25, 2015
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:
Vitamin D deficiency is a risk factor for mortality but existing data are limited by missing standardization of laboratory methods for 25-hydroxyvitamin D (25[OH]D). In a European consortium of eight cohort studies we use protocols of the Vitamin D Standardization Program (VDSP) to obtain standardized 25(OH)D data. Individual participant data (IPD) meta-analyses using a one step procedure will be performed to study associations of original and standardized 25(OH)D with all-cause, cardiovascular, and cancer mortality.

Condition or disease
Vitamin D Deficiency

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Study Type : Observational
Actual Enrollment : 26916 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vitamin D and Mortality: an Individual Participant Data Meta-analysis of Standardized 25-hydroxyvitamin D in 26916 Individuals of a European Consortium
Study Start Date : April 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Median follow-up time of the included studies ranges from 7.5 to 17.8 years ]

Secondary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: Follow-up time - Median follow-up time of the included studies ranges from 7.5 to 17.8 years ]
  2. Cancer mortality [ Time Frame: Follow-up time - Median follow-up time of the included studies ranges from 7.5 to 17.8 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The fourth Tromsø study, the Ludwigshafen Risk and Cardiovascular Health Study (LURIC), the Age, Gene/Environment Susceptibility-Reykjavik Study (AGES Reykjavik), the New Hoorn Study (NHS), the Aarhus Mammography Cohort Study, the German Health Interview and Examination Survey for Adults (DEGS) and the old and young cohort of the Longitudinal Study on Ageing in Amsterdam (LASA).
Criteria

Inclusion Criteria:

Availability of quality bio-banked samples for uniform sampling and analysis of selected samples

Validated prospective data on clinical outcomes

Willingness to collaborate

Expertise in the field.

Exclusion Criteria:

Individuals with incomplete data on age, sex, body mass index (BMI), season of blood sampling, 25(OH)D levels, vital status at follow-up and follow-up-time.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438488


Locations
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Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
European Union
Investigators
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Principal Investigator: Stefan Pilz, PhD Medical University of Graz
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02438488    
Other Study ID Numbers: ODIN 1
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders