Vitamin D DeficiencyNCT00267540
The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls
A study testing cholecalciferol (D3) (vitamin) in people with Vitamin D Deficiency, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13. More specifically the effects on the following parameters will be assessed: Vitamin D metabolites. Parathyroid hormone. Bone turnover. Bone mineral accretion. Read more about this study
- Who is it for?
- Ages 10 to 11 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- cholecalciferol (D3) (vitamin)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 225 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2001to Dec 2003
- 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 10 to 11 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Girls born in Denmark with Danish citizenship aged 10.0-11.0 years living in the municipals of Copenhagen and Frederiksberg
Who cannot join
- Any chronical disease with influence on bone mass or turnover
- Intake of drugs with influence on bone mass or turnover
- Intake of calcium or vitamin D other than the intervention
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, The Royal Veterinary and Agricultural University
Frederiksberg, DK 1958
About this study
Official title: Adolescent Girls-Impact of Vitamin D on Bone Accretion Work Package 1 (Danish Part) of OPTIFORD (Towards A Strategy for Optimal Vitamin D Fortification)
Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13.
More specifically the effects on the following parameters will be assessed:
- Vitamin D metabolites.
- Parathyroid hormone.
- Bone turnover.
- Bone mineral accretion.
- Serum calcium and phosphate.
- Renal handling of calcium and phosphate.
Read the detailed description
This work package will consist of a randomised double blind one-year vitamin D supplementation study. Primary effect parameter is change in bone mineral content and therefore study duration will be one year. A total of 225 subjects, 75 in each of the three groups: one control and two intervention groups, will be included Two dosages of supplementation will be used: 5 µg per day and 10 µg per day.
- Conditions
- Vitamin D Deficiency
- Being tested
- cholecalciferol (D3) (vitamin)
- Keywords
- Vitamin D, adolescent girls, bone accretion, bone turn over, vitamin D status, Vitamin D insufficiency in young girls
- 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.
cholecalciferol (D3) (vitamin)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year.
Bone accretion measured by DXA. Measurement at baseline and after one year.
Bone turnover measured at baseline, half a year and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startJan 2001
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Double blind
- Enrolment
- 225 participants
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Seventh Framework Programme
- Investigators
- Christian Mølgaard, MD, PhD, Principal investigator, The Royal Veterinary and Agricultural University, Frederiksberg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267540
- Sponsor's protocol ID
- QLK1-CT-2000-00623
- Status last verified
- Jan 2008
- First submitted
- 20 Dec 2005
- Last updated
- 30 Jan 2008
- Results posted
- No
Publications
Cashman KD, FitzGerald AP, Viljakainen HT, Jakobsen J, Michaelsen KF, Lamberg-Allardt C, Molgaard C. Estimation of the dietary requirement for vitamin D in healthy adolescent white girls. Am J Clin Nutr. 2011 Mar;93(3):549-55. doi: 10.3945/ajcn.110.006577. Epub 2011 Jan 26.
PubMed 21270380
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Girls-Impact of Vitamin D on Bone Accretion Work Package 1 (Danish Part) of OPTIFORD (Towards A Strategy for Optimal Vitamin D Fortification)
- ClinicalTrials.gov ID
- NCT00267540
- Acronym / sponsor ID
- QLK1-CT-2000-00623
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, adolescent girls, bone accretion, bone turn over, vitamin D status, Vitamin D insufficiency in young girls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Seventh Framework Programme
- Study start
- Jan 2001
- Study completion
- Dec 2003
- First posted
- 21 Dec 2005 (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.
Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13.
More specifically the effects on the following parameters will be assessed:
- Vitamin D metabolites.
- Parathyroid hormone.
- Bone turnover.
- Bone mineral accretion.
- Serum calcium and phosphate.
- Renal handling of calcium and phosphate.
Detailed description
This work package will consist of a randomised double blind one-year vitamin D supplementation study. Primary effect parameter is change in bone mineral content and therefore study duration will be one year. A total of 225 subjects, 75 in each of the three groups: one control and two intervention groups, will be included Two dosages of supplementation will be used: 5 µg per day and 10 µg per day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 10 to 11 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Girls born in Denmark with Danish citizenship aged 10.0-11.0 years living in the municipals of Copenhagen and Frederiksberg
Key exclusion criteria (3 listed)
- Any chronical disease with influence on bone mass or turnover
- Intake of drugs with influence on bone mass or turnover
- Intake of calcium or vitamin D other than the intervention
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 |
|---|---|---|
| cholecalciferol (D3) (vitamin) | Behavioural | – |
Primary outcome
Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year.
Bone accretion measured by DXA. Measurement at baseline and after one year.
Bone turnover measured at baseline, half a year and one year
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 30 Jan 2008.
- Derived from this study: PubMed 21270380Cashman KD, FitzGerald AP, Viljakainen HT, Jakobsen J, Michaelsen KF, Lamberg-Allardt C, Molgaard C. Estimation of the dietary requirement for vitamin D in healthy adolescent white girls. Am J Clin Nutr. 2011 Mar;93(3):549-55. doi: 10.3945/ajcn.110.006577. Epub 2011 Jan 26.
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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, MD, PhD principal investigator
The Royal Veterinary and Agricultural University, Frederiksberg, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferol (D3) (vitamin) 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 1 inclusion and 3 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 30 Jan 2008. 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. 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?
Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year.. The study lists 3 primary outcomes in all. 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 NCT00267540, which also lists 1 linked publication.
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 30 Jan 2008.