NCT02136407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
615

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

May 2, 2014

Last Update Submit

May 12, 2014

Conditions

Vitamin-D Insufficiency

Keywords

Vitamin Dvitamin D deficiencyparathyroid hormone

Outcome Measures

Primary Outcomes (1)

  • Inter-individual and intra-individual varations in serum 25-hydroxy vitamin-D during different seasons.

    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.

Study Arms (2)

Blood donors

N=540

Thrombocyte donors

N=75

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Blood donors

You may qualify if:

  • healthy at the time of donating blood

You may not qualify if:

  • unhealthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 2, 2014

First Posted

May 13, 2014

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations

SE(1)