Vitamin D DeficiencyODIN JuniorNCT02145195
The Effect of Vitamin D Supplements on Vitamin D Status, Cardiometabolic Health and Immune Defense in Danish Children
A study testing Vitamin D3 (cholecalciferol) in people with Vitamin D Deficiency, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The main purpose of this study is to investigate whether and in which doses vitamin D intake is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children during wintertime. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D3 (cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4-8 years at the start of the intervention
- healthy
- of white, Danish/European origin
- children must be Danish-speaking
- parents must read and speak Danish
- not planning a winter vacation south of a latitude of 51°North (corresponding to Surrey, England)
Who cannot join
- diseases that may interfere with vitamin D or calcium metabolism
- intake of medication known to affect vitamin D or calcium metabolism
- use of vitamin D containing supplements ≥ 4 days/week the last 8 weeks before intervention start and use of any vitamin D containing supplements the last 4 weeks before intervention start
- concomitant participation in other studies involving dietary supplements or blood sampling
- serum calcium > 2.7 mmol/L at baseline
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, 1958
About this study
Official title: Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior
The main purpose of this study is to investigate whether and in which doses vitamin D intake is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children during wintertime.
Read the detailed description
The main objective of ODIN Junior is to investigate whether and in which doses vitamin D intake is needed in order to maintain serum 25(OH)D concentrations above deficiency and insufficiency cut-offs (30 nmol/L and 50 nmol/L, respectively) in 4-8 year-old Danish children during the winter time. The children will be randomized to receive tablets with either 10 micrograms/day or 20 microgram/day of vitamin D3 (cholecalciferol), corresponding to one and two times the recommended daily intake in children, or placebo for 20 weeks. Measurements and blood sampling will be performed before the beginning and by the end of the intervention.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D3 (cholecalciferol)
- Keywords
- Vitamin D, Children, Supplements, Cardiometabolic markers, Immune defense, Bone turnover, Muscle strength
- 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.
Vitamin D3 (cholecalciferol)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D (10 microgram/day) | Experimental | Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks. Receives: Dietary Supplement: Vitamin D3 (cholecalciferol) |
| Vitamin D (20 microgram/day) | Experimental | Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks. Receives: Dietary Supplement: Vitamin D3 (cholecalciferol) |
| Placebo control | Placebo comparator | Tablets with 0 microgram vitamin D daily for 20 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vitamin D status
Serum concentrations of total 25-hydroxyvitamin D [25(OH)D]
Measured: Baseline and 20 weeks
Secondary outcomes (3)
Change in anthropometric measurements
Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.
Measured: Baseline and 20 weeks
Change in body composition
Fat mass, fat mass index (kg/m2), fat free mass and fat free mass index (kg/m2).
Measured: Baseline and 20 weeks
Serum calcium
Serum calcium (adjusted for albumin) evaluated after the first visit has been completed for all children, and after the second visit.
Measured: Baseline and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startJun 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 (4)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University College Cork, University of Surrey
- Responsible party
- Principal investigator, Christian Mølgaard, University of Copenhagen
- Investigators
- Christian Mølgaard, PhD, MD, Principal investigator, Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145195
- Sponsor's protocol ID
- D214
- Other IDs
- European Commission
- Acronym
- ODIN Junior
- Status last verified
- Mar 2015
- First submitted
- 20 May 2014
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Sun behaviour and physical activity associated with autumn vitamin D status in 4-8-year-old Danish children. Public Health Nutr. 2018 Dec;21(17):3158-3167. doi: 10.1017/S1368980018002094. Epub 2018 Sep 7.
PubMed 30189911Hauger H, Molgaard C, Mortensen C, Ritz C, Frokiaer H, Smith TJ, Hart K, Lanham-New SA, Damsgaard CT. Winter Cholecalciferol Supplementation at 55 degrees N Has No Effect on Markers of Cardiometabolic Risk in Healthy Children Aged 4-8 Years. J Nutr. 2018 Aug 1;148(8):1261-1268. doi: 10.1093/jn/nxy080.
PubMed 29917069Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Winter vitamin D3 supplementation does not increase muscle strength, but modulates the IGF-axis in young children. Eur J Nutr. 2019 Apr;58(3):1183-1192. doi: 10.1007/s00394-018-1637-x. Epub 2018 Feb 15.
PubMed 29450728Mortensen C, Damsgaard CT, Hauger H, Ritz C, Lanham-New SA, Smith TJ, Hennessy A, Dowling K, Cashman KD, Kiely M, Molgaard C. Estimation of the dietary requirement for vitamin D in white children aged 4-8 y: a randomized, controlled, dose-response trial. Am J Clin Nutr. 2016 Nov;104(5):1310-1317. doi: 10.3945/ajcn.116.136697. Epub 2016 Oct 12.
PubMed 27733403
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 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) Junior
- ClinicalTrials.gov ID
- NCT02145195
- Acronym / sponsor ID
- ODIN Junior / D214
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Children, Supplements, Cardiometabolic markers, Immune defense, Bone turnover, Muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University College Cork, University of Surrey
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 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 main purpose of this study is to investigate whether and in which doses vitamin D intake is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children during wintertime.
Detailed description
The main objective of ODIN Junior is to investigate whether and in which doses vitamin D intake is needed in order to maintain serum 25(OH)D concentrations above deficiency and insufficiency cut-offs (30 nmol/L and 50 nmol/L, respectively) in 4-8 year-old Danish children during the winter time. The children will be randomized to receive tablets with either 10 micrograms/day or 20 microgram/day of vitamin D3 (cholecalciferol), corresponding to one and two times the recommended daily intake in children, or placebo for 20 weeks. Measurements and blood sampling will be performed before the beginning and by the end of the intervention.
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 |
|---|---|---|
| Vitamin D (10 microgram/day) | Experimental | Dietary Supplement: Vitamin D3 (cholecalciferol)Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks. |
| Vitamin D (20 microgram/day) | Experimental | Dietary Supplement: Vitamin D3 (cholecalciferol)Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks. |
| Placebo control | Placebo comparator | –Tablets with 0 microgram vitamin D daily for 20 weeks. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 4-8 years at the start of the intervention
- healthy
- of white, Danish/European origin
- children must be Danish-speaking
- parents must read and speak Danish
Key exclusion criteria (5 listed)
- diseases that may interfere with vitamin D or calcium metabolism
- intake of medication known to affect vitamin D or calcium metabolism
- use of vitamin D containing supplements ≥ 4 days/week the last 8 weeks before intervention start and use of any vitamin D containing supplements the last 4 weeks before intervention start
- concomitant participation in other studies involving dietary supplements or blood sampling
- serum calcium > 2.7 mmol/L at baseline
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 (cholecalciferol) | Dietary supplement | Vitamin D (10 microgram/day), Vitamin D (20 microgram/day) |
Primary outcome
Change in vitamin D status
Time frame: Baseline and 20 weeks
Serum concentrations of total 25-hydroxyvitamin D [25(OH)D]
3 secondary outcomes
Change in anthropometric measurements
Time frame: Baseline and 20 weeks
Change in body composition
Time frame: Baseline and 20 weeks
Serum calcium
Time frame: Baseline and 20 weeks
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 25 Mar 2015.
- Derived from this study: PubMed 30189911Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Sun behaviour and physical activity associated with autumn vitamin D status in 4-8-year-old Danish children. Public Health Nutr. 2018 Dec;21(17):3158-3167. doi: 10.1017/S1368980018002094. Epub 2018 Sep 7.
- Derived from this study: PubMed 29917069Hauger H, Molgaard C, Mortensen C, Ritz C, Frokiaer H, Smith TJ, Hart K, Lanham-New SA, Damsgaard CT. Winter Cholecalciferol Supplementation at 55 degrees N Has No Effect on Markers of Cardiometabolic Risk in Healthy Children Aged 4-8 Years. J Nutr. 2018 Aug 1;148(8):1261-1268. doi: 10.1093/jn/nxy080.
- Derived from this study: PubMed 29450728Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Winter vitamin D3 supplementation does not increase muscle strength, but modulates the IGF-axis in young children. Eur J Nutr. 2019 Apr;58(3):1183-1192. doi: 10.1007/s00394-018-1637-x. Epub 2018 Feb 15.
- Derived from this study: PubMed 27733403Mortensen C, Damsgaard CT, Hauger H, Ritz C, Lanham-New SA, Smith TJ, Hennessy A, Dowling K, Cashman KD, Kiely M, Molgaard C. Estimation of the dietary requirement for vitamin D in white children aged 4-8 y: a randomized, controlled, dose-response trial. Am J Clin Nutr. 2016 Nov;104(5):1310-1317. doi: 10.3945/ajcn.116.136697. Epub 2016 Oct 12.
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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.
Christian Mølgaard, PhD, MD principal investigator
Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen
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 (cholecalciferol) in people with Vitamin D Deficiency, run by University of Copenhagen at 1 site in Denmark.
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 6 inclusion and 5 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 25 Mar 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 Denmark. 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?
Change in vitamin D status (time frame: Baseline and 20 weeks). 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 NCT02145195, which also lists 4 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 25 Mar 2015.