Serum 25-hydroxyvitamin D Concentrations (25OHD)NCT02150122
Dietary Requirement for Vitamin D in Adolescents Aged 14-18 Years
A study testing Vitamin D3 in people with Serum 25-hydroxyvitamin D Concentrations (25OHD), run by University of Surrey at 1 site in United Kingdom.
Trial summary
It is known that low vitamin D status is a very common problem in the UK. It is also known that a lack of vitamin D availability has potentially serious health implications, especially with respect to bone and muscle function. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Serum 25-hydroxyvitamin D Concentrations (25OHD)
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Mar 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female
- Aged between 14 and 18 years
- Caucasian ethnicity
- In good health
- Written informed consent from the adolescent (and parent if required)
Who cannot join
- Currently receiving treatment for medical conditions likely to affect vitamin D metabolism
- Hypercalcaemia (>2.5mmol/l)
- Regular use of sun-beds
- Having a sun holiday one month prior to commencing the trial or plans for a sun holiday within the study period.
- Use of vitamin supplements containing vitamin D - if the prospective participant agrees to stop vitamin D supplementation to join the study, a wash-out period of 8 weeks prior to commencing the trial would be acceptable.
- Excessive consumption of alcohol (>14 units per week for females, >21 units per week for males)
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- Smoking >10 cigarettes per day
- Those following a weight-reducing diet or under dietary restriction (except vegetarianism)
- Known intolerance/allergy to the constituent ingredients of the daily supplement
- Clinically significant haematological abnormalities other than mild anaemia (Hb<12.0g/dl)
- Active malignancy
- Pregnant or planning a pregnancy during the study period.
- Breast-feeding mothers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-response, Double-blind Randomised Placebo-controlled Trial to Estimate the Dietary Requirement for Vitamin D in Caucasian Male and Female Adolescents Aged 14-18 Years (The ODIN Study)
It is known that low vitamin D status is a very common problem in the UK. It is also known that a lack of vitamin D availability has potentially serious health implications, especially with respect to bone and muscle function. Much research has recently taken place to establish the vitamin D requirements of key population groups (i.e. pregnant women, the elderly, ethnic minorities). However few data are available describing the vitamin D requirements for male and female adolescents. The period of adolescence is a key stage of growth and development - poor nutrition during this time can have detrimental health consequences for a lifetime.
No intervention studies have comprehensively investigated the vitamin D requirements of adolescents. The proposed ODIN Study will enable a better understanding of how adolescents respond to vitamin D supplementation and the most effective daily amount that will raise and maintain vitamin D status in adolescents during the winter-time. In addition, investigations into the mechanisms of action with respect to any differences observed across the doses of vitamin D and between the genders of the participants will also provide key information. Mechanisms of action will focus on genetic differences as well as differences in vitamin D metabolising enzymes.
Read more
The results obtained from this significant study will not only inform the European Food Standards Agency (EFSA) with respect to their imminent deliberations regarding vitamin D recommendations. The ODIN Study will also inform the UK Department of Health's Scientific Advisory Committee on Nutrition (SACN), the wider scientific community and be a critical resource for key stakeholders (i.e. food industry, government health agencies) to collaborate in determining future public health strategies, thus potentially positively impacting on the health of the population for years to come.
The investigators propose that the daily supplementation of 10µg/day (400 IU) and 20µg/day (800 IU) of vitamin D3 for five months will meet the vitamin D requirements of males and females aged 14-18 year and will be sufficient to maintain winter-time 25OHD levels above a range of thresholds between 30 and 50nmol/l.
- Being tested
- Vitamin D3
- Keywords
- Vitamin D, Serum 25-hydroxyvitamin D (25OHD), Adolescents
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 |
|---|---|---|
| 10 micrograms (400 IU) vitamin D3 | Experimental | Participants will be given a daily supplement containing 10 micrograms (400 IU) vitamin D3 to take for 5 months. Receives: Dietary Supplement: Vitamin D3 |
| 20 micrograms (800 IU) vitamin D3 | Experimental | Participants will be given a daily supplement containing 20 micrograms (800 IU) vitamin D3 to take for 5 months. Receives: Dietary Supplement: Vitamin D3 |
| Placebo | No intervention | Participants will be given a placebo, similar in appearance to the vitamin D3 tablets, to take for 5 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-hydroxyvitamin D concentrations
To investigate the vitamin D intakes needed to maintain serum 25-hydroxyvitamin D (25OHD) concentrations above the deficiency and insufficiency cut off thresholds (30nmol/l and 50nmol/l respectively) in male and female adolescents during the winter time.
Measured: Baseline and after 5 months of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Lanham-New, Professor, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150122
- Sponsor's protocol ID
- ODIN/1213
- Status last verified
- Mar 2016
- First submitted
- 23 May 2014
- Last updated
- 2 Mar 2016
- Results posted
- No
Publications
Smith TJ, Tripkovic L, Hauger H, Damsgaard CT, Molgaard C, Lanham-New SA, Hart KH. Winter Cholecalciferol Supplementation at 51 degrees N Has No Effect on Markers of Cardiometabolic Risk in Healthy Adolescents Aged 14-18 Years. J Nutr. 2018 Aug 1;148(8):1269-1275. doi: 10.1093/jn/nxy079.
PubMed 29920594Smith TJ, Tripkovic L, Damsgaard CT, Molgaard C, Ritz C, Wilson-Barnes SL, Dowling KG, Hennessy A, Cashman KD, Kiely M, Lanham-New SA, Hart KH. Estimation of the dietary requirement for vitamin D in adolescents aged 14-18 y: a dose-response, double-blind, randomized placebo-controlled trial. Am J Clin Nutr. 2016 Nov;104(5):1301-1309. doi: 10.3945/ajcn.116.138065. Epub 2016 Sep 21.
PubMed 27655438
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-response, Double-blind Randomised Placebo-controlled Trial to Estimate the Dietary Requirement for Vitamin D in Caucasian Male and Female Adolescents Aged 14-18 Years (The ODIN Study)
- ClinicalTrials.gov ID
- NCT02150122
- Acronym / sponsor ID
- ODIN/1213
- Keywords
- Vitamin D, Serum 25-hydroxyvitamin D (25OHD), Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 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.
It is known that low vitamin D status is a very common problem in the UK. It is also known that a lack of vitamin D availability has potentially serious health implications, especially with respect to bone and muscle function. Much research has recently taken place to establish the vitamin D requirements of key population groups (i.e. pregnant women, the elderly, ethnic minorities). However few data are available describing the vitamin D requirements for male and female adolescents. The period of adolescence is a key stage of growth and development - poor nutrition during this time can have detrimental health consequences for a lifetime.
No intervention studies have comprehensively investigated the vitamin D requirements of adolescents. The proposed ODIN Study will enable a better understanding of how adolescents respond to vitamin D supplementation and the most effective daily amount that will raise and maintain vitamin D status in adolescents during the winter-time. In addition, investigations into the mechanisms of action with respect to any differences observed across the doses of vitamin D and between the genders of the participants will also provide key information. Mechanisms of action will focus on genetic differences as well as differences in vitamin D metabolising enzymes.
The results obtained from this significant study will not only inform the European Food Standards Agency (EFSA) with respect to their imminent deliberations regarding vitamin D recommendations. The ODIN Study will also inform the UK Department of Health's Scientific Advisory Committee on Nutrition (SACN), the wider scientific community and be a critical resource for key stakeholders (i.e. food industry, government health agencies) to collaborate in determining future public health strategies, thus potentially positively impacting on the health of the population for years to come.
The investigators propose that the daily supplementation of 10µg/day (400 IU) and 20µg/day (800 IU) of vitamin D3 for five months will meet the vitamin D requirements of males and females aged 14-18 year and will be sufficient to maintain winter-time 25OHD levels above a range of thresholds between 30 and 50nmol/l.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 10 micrograms (400 IU) vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Participants will be given a daily supplement containing 10 micrograms (400 IU) vitamin D3 to take for 5 months. |
| 20 micrograms (800 IU) vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Participants will be given a daily supplement containing 20 micrograms (800 IU) vitamin D3 to take for 5 months. |
| Placebo | No intervention | –Participants will be given a placebo, similar in appearance to the vitamin D3 tablets, to take for 5 months. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or female
- Aged between 14 and 18 years
- Caucasian ethnicity
- In good health
- Written informed consent from the adolescent (and parent if required)
Key exclusion criteria (13 listed)
- Currently receiving treatment for medical conditions likely to affect vitamin D metabolism
- Hypercalcaemia (>2.5mmol/l)
- Regular use of sun-beds
- Having a sun holiday one month prior to commencing the trial or plans for a sun holiday within the study period.
- Use of vitamin supplements containing vitamin D - if the prospective participant agrees to stop vitamin D supplementation to join the study, a wash-out period of 8 weeks prior to commencing the trial would be acceptable.
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 | 10 micrograms (400 IU) vitamin D3, 20 micrograms (800 IU) vitamin D3 |
Primary outcome
Serum 25-hydroxyvitamin D concentrations
Time frame: Baseline and after 5 months of supplementation
To investigate the vitamin D intakes needed to maintain serum 25-hydroxyvitamin D (25OHD) concentrations above the deficiency and insufficiency cut off thresholds (30nmol/l and 50nmol/l respectively) in male and female adolescents during the winter time.
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 2 Mar 2016.
- Derived from this study: PubMed 29920594Smith TJ, Tripkovic L, Hauger H, Damsgaard CT, Molgaard C, Lanham-New SA, Hart KH. Winter Cholecalciferol Supplementation at 51 degrees N Has No Effect on Markers of Cardiometabolic Risk in Healthy Adolescents Aged 14-18 Years. J Nutr. 2018 Aug 1;148(8):1269-1275. doi: 10.1093/jn/nxy079.
- Derived from this study: PubMed 27655438Smith TJ, Tripkovic L, Damsgaard CT, Molgaard C, Ritz C, Wilson-Barnes SL, Dowling KG, Hennessy A, Cashman KD, Kiely M, Lanham-New SA, Hart KH. Estimation of the dietary requirement for vitamin D in adolescents aged 14-18 y: a dose-response, double-blind, randomized placebo-controlled trial. Am J Clin Nutr. 2016 Nov;104(5):1301-1309. doi: 10.3945/ajcn.116.138065. Epub 2016 Sep 21.
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.
Susan Lanham-New, Professor principal investigator
University of Surrey
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 Surrey at 1 site in United Kingdom.
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 5 inclusion and 13 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 2 Mar 2016. 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 United Kingdom. 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?
Serum 25-hydroxyvitamin D concentrations (time frame: Baseline and after 5 months of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150122, which also lists 2 linked publications.
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 2 Mar 2016.