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Seasonal Variations in Serum 25-hydroxy Vitamin-D Levels in a Swedish Cohort

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: NCT02136407
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Eva Klingberg, Sahlgrenska University Hospital, Sweden

Tracking Information
First Submitted Date May 2, 2014
First Posted Date May 13, 2014
Last Update Posted Date May 13, 2014
Study Start Date October 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 12, 2014)
Inter-individual and intra-individual varations in serum 25-hydroxy vitamin-D during different seasons. [ Time Frame: Group1:Blood donors, single test, 25(OH)vit D at inclusion . Group 2: thrombocyte donors: multiple tests, serum 25(OH)vit D during 8 months. ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Seasonal Variations in Serum 25-hydroxy Vitamin-D Levels in a Swedish Cohort
Official Title Seasonal Variations in Serum 25-hydroxy Vitamin-D Levels in a Swedish Cohort
Brief Summary The purpose of this study was to study seasonal inter-individual and intra-individual variations in S-25(OH)D and to explore parameters associated with S-25-OHD in healthy Swedish adults.
Detailed Description Serum was collected during 12 months and analysed for 25(OH)D in 540 healthy blood donors. The blood donors answered questionnaires concerning vitamin D supplements, smoking, physical activity, sunbed use and holidays in sunny locations. Repeated serum samples were also collected from thrombocyte donors to study the intra-individual variations in S-25(OH)D.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum
Sampling Method Probability Sample
Study Population Blood donors
Condition Vitamin-D Insufficiency
Intervention Not Provided
Study Groups/Cohorts
  • Blood donors
    N=540
  • Thrombocyte donors
    N=75
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 12, 2014)
615
Original Actual Enrollment Same as current
Actual Study Completion Date September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • healthy at the time of donating blood

Exclusion Criteria:

  • unhealthy
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02136407
Other Study ID Numbers EPN399-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eva Klingberg, Sahlgrenska University Hospital, Sweden
Study Sponsor Sahlgrenska University Hospital, Sweden
Collaborators Not Provided
Investigators Not Provided
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date May 2014