Serum 25-hydroxyvitamin D Concentrations (25OHD)ODINNCT02212223
Marwo-D Research -Need for Vitamin D in Different Population Groups
A study testing Vitamin D3 in people with Serum 25-hydroxyvitamin D Concentrations (25OHD), run by University of Helsinki at 1 site in Finland.
Trial summary
Insufficient intake of vitamin D is a public health problem, affecting about 40% of the Finnish population in the winter. Vitamin D has a wide range of health effects: in addition to its effect on bone, it is known to affect inflammatory response among other things. Read more about this study
- Who is it for?
- Ages 21 to 66 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Serum 25-hydroxyvitamin D Concentrations (25OHD)
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2014to May 2015
- Phase
- Interventional
- 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 21 to 66 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- woman between 21-66 years of age
- belongs to original Finnish population or to Somali immigrant population
- healthy (= no disease requiring medication)
- lives in the metropolitan area
Who cannot join
- pregnant or breastfeeding
- has traveled to a sunny destination or destination near the equator during the previous month
- plans to travel to a sunny destination or destination near the equator in the next 6 months
- has used a tanning bed during the previous month
- plans to use a tanning bed in the next 6 months
- the subject's blood 25-hydroxy-vitamin D level (25 (OH) D), exceeds 100 nmol / L or is less than 30 nmol / L at baseline in the screening phase.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Food and Environmental Sciences, University of Helsinki
Helsinki
About this study
Official title: Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)
Insufficient intake of vitamin D is a public health problem, affecting about 40% of the Finnish population in the winter. Vitamin D has a wide range of health effects: in addition to its effect on bone, it is known to affect inflammatory response among other things. The sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements. In Finland and in Northern Europe vitamin D is formed in the skin only from March to October. This alone is not sufficient to cover the need for year-round, because vitamin D storage is used in a few months. During the winter months the only sources of vitamin D are diet and vitamin preparations. Current vitamin D recommendations are usually based on studies in white population. However, there can be a difference in the need of vitamin D and in vitamin D metabolism between different population groups. More research evidence is needed from the northern countries. The aim of this study is to evaluate the vitamin D need in Somali immigrant population and in original Finnish population. The hypothesis is that the Somalis need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than the original Finnish population.
- Being tested
- Vitamin D3
- Keywords
- Vitamin D, Serum 25-hydroxyvitamin D (25OHD), Dietary supplement, Ethnicity, Immigrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3 | Experimental | Subjects belonging to Somali immigrant population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months Receives: Dietary Supplement: Vitamin D3 |
| Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3 | Experimental | Subjects belonging to Somali immigrant population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months Receives: Dietary Supplement: Vitamin D3 |
| Group 3: Somali immigrant group, 0 µg vitamin D3 | Placebo comparator | Subjects belonging to Somali immigrant population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months |
| Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3 | Experimental | Subjects belonging to original Finnish population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months. Receives: Dietary Supplement: Vitamin D3 |
| Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3 | Experimental | Subjects belonging to original Finnish population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months. Receives: Dietary Supplement: Vitamin D3 |
| Group 6: Original Finnish group, 0 µg vitamin D3 | Placebo comparator | Subjects belonging to original Finnish population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-hydroxyvitamin D (25(OH)D) concentrations
The effect of ethnicity on the serum 25(OH)D concentration response to vitamin D supplementation will be investigated.
Measured: Change from baseline in serum 25(OH)D concentration at 3 and 6 months
Secondary outcomes (2)
Serum calcium concentration
Markers of calcium metabolism, which are affected by vitamin D, will be measured
Measured: Change from baseline in serum calcium concentration at 3 and 6 months
Serum parathyroid hormone (PTH) concentration
Markers of calcium metabolism, which are affected by vitamin D, will be measured
Measured: Change from baseline in serum PTH concentration at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum 25-hydroxyvitamin D Concentrations (25OHD)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork, Technical University of Denmark, Finnish Institute for Health and Welfare
- Responsible party
- Principal investigator, Christel Lamberg-Allardt, University of Helsinki
- Investigators
- Christel Lamberg-Allardt, Professor, Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212223
- Sponsor's protocol ID
- Helsinki U
- Acronym
- ODIN
- Status last verified
- Jul 2015
- First submitted
- 6 Aug 2014
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)
- ClinicalTrials.gov ID
- NCT02212223
- Acronym / sponsor ID
- ODIN / Helsinki U
- Keywords
- Vitamin D, Serum 25-hydroxyvitamin D (25OHD), Dietary supplement, Ethnicity, Immigrant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- University College Cork, Technical University of Denmark, Finnish Institute for Health and Welfare
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 Aug 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.
Insufficient intake of vitamin D is a public health problem, affecting about 40% of the Finnish population in the winter. Vitamin D has a wide range of health effects: in addition to its effect on bone, it is known to affect inflammatory response among other things. The sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements. In Finland and in Northern Europe vitamin D is formed in the skin only from March to October. This alone is not sufficient to cover the need for year-round, because vitamin D storage is used in a few months. During the winter months the only sources of vitamin D are diet and vitamin preparations. Current vitamin D recommendations are usually based on studies in white population. However, there can be a difference in the need of vitamin D and in vitamin D metabolism between different population groups. More research evidence is needed from the northern countries. The aim of this study is to evaluate the vitamin D need in Somali immigrant population and in original Finnish population. The hypothesis is that the Somalis need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than the original Finnish population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Subjects belonging to Somali immigrant population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months |
| Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Subjects belonging to Somali immigrant population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months |
| Group 3: Somali immigrant group, 0 µg vitamin D3 | Placebo comparator | –Subjects belonging to Somali immigrant population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months |
| Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Subjects belonging to original Finnish population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months. |
| Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Subjects belonging to original Finnish population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months. |
| Group 6: Original Finnish group, 0 µg vitamin D3 | Placebo comparator | –Subjects belonging to original Finnish population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months. |
Who may qualify
- Ages
- 21 to 66 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- woman between 21-66 years of age
- belongs to original Finnish population or to Somali immigrant population
- healthy (= no disease requiring medication)
- lives in the metropolitan area
Key exclusion criteria (6 listed)
- pregnant or breastfeeding
- has traveled to a sunny destination or destination near the equator during the previous month
- plans to travel to a sunny destination or destination near the equator in the next 6 months
- has used a tanning bed during the previous month
- plans to use a tanning bed in the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 | Dietary supplement | Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3, Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3, Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3, Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3 |
Primary outcome
Serum 25-hydroxyvitamin D (25(OH)D) concentrations
Time frame: Change from baseline in serum 25(OH)D concentration at 3 and 6 months
The effect of ethnicity on the serum 25(OH)D concentration response to vitamin D supplementation will be investigated.
2 secondary outcomes
Serum calcium concentration
Time frame: Change from baseline in serum calcium concentration at 3 and 6 months
Serum parathyroid hormone (PTH) concentration
Time frame: Change from baseline in serum PTH concentration at 3 and 6 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 14 Jul 2015.
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.
Christel Lamberg-Allardt, Professor study director
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Serum 25-hydroxyvitamin D Concentrations (25OHD), run by University of Helsinki at 1 site in Finland.
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 4 inclusion and 6 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 14 Jul 2015. 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 Finland. 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. Some participants in this study may receive a placebo. 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?
Serum 25-hydroxyvitamin D (25(OH)D) concentrations (time frame: Change from baseline in serum 25(OH)D concentration at 3 and 6 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 14 Jul 2015.