Vitamin-D InsufficiencyNCT02136407
Seasonal Variations in Serum 25-hydroxy Vitamin-D Levels in a Swedish Cohort
An observational study of Vitamin-D Insufficiency, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin-D Insufficiency
- How many people
- 615 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2009to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Blood donors
Who may be able to join
- healthy at the time of donating blood
Who cannot join
- unhealthy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vitamin-D Insufficiency
- Keywords
- Vitamin D, vitamin D deficiency, parathyroid hormone
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Blood donors | N=540 | |
| Thrombocyte donors | N=75 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-individual and intra-individual varations in serum 25-hydroxy vitamin-D during different seasons.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin-D InsufficiencyStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Klingberg, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136407
- Sponsor's protocol ID
- EPN399-09
- Status last verified
- May 2014
- First submitted
- 2 May 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonal Variations in Serum 25-hydroxy Vitamin-D Levels in a Swedish Cohort
- ClinicalTrials.gov ID
- NCT02136407
- Acronym / sponsor ID
- EPN399-09
- Conditions
- Vitamin-D Insufficiency
- Keywords
- Vitamin D, vitamin D deficiency, parathyroid hormone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood donors | – | –N=540 |
| Thrombocyte donors | – | –N=75 |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Blood donors
Key inclusion criteria (1 listed)
- healthy at the time of donating blood
Key exclusion criteria (1 listed)
- unhealthy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
Related trials for Vitamin-D Insufficiency
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Recruiting
Supplementation of Cholecalciferol and Related Active Metabolites Through Bioenhancing Layer's Eggs
Healthy Adult Participants, Vitamin D Insufficiency
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin-D Insufficiency, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.