Hypovitaminosis DPhase 4NCT01067898
A Study on Oral Vitamin D Megadoses
A Phase 4 study testing vitamin D3 (cholecalciferol), olive oil and calcium carbonate in people with Hypovitaminosis D, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to determine if infrequent administration of oral vitamin D megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels of 50-75 nmol/L. Read more about this study
- Who is it for?
- Ages 70 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypovitaminosis D
- What is being tested?
- vitamin D3 (cholecalciferol), olive oil and calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2010to May 2011
- Phase
- Phase 4
- 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 70 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- female
- 70-80 yrs old
Who cannot join
- disease or medication affecting calcium homeostasis
- renal failure (Pt-GFRe-CG < 35 ml/min)
Trial locations and contacts
1 site in 1 country.
Finland1 site
Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
Helsinki, FI-00029 HUS
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months
The purpose of this study is to determine if infrequent administration of oral vitamin D megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin D3 in every three months would be effective and safe treatment to achieve the target levels.
- Conditions
- Hypovitaminosis D
- Being tested
- vitamin D3 (cholecalciferol), olive oil, calcium carbonate
- Keywords
- vitamin D supplementation, cholecalciferol, PTH, bone turnover markers, elderly women
- 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
Also called Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/ml
vitamin D3 (cholecalciferol) oil 20 000 IU/ml, oral dose of 200 000 IU or 100 000 IU (10ml or 5ml) every three months for one year.
olive oilOther
10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year
calcium carbonateDietary supplement
1000 mg calcium per os every day for one year
| Study group | Role | What they receive |
|---|---|---|
| 200 000 IU vitamin D3 every three months | Experimental | Not described Receives: Dietary Supplement: vitamin D3 (cholecalciferol); Dietary Supplement: calcium carbonate |
| 100 000 IU vitamin D3 every three months | Experimental | Not described Receives: Dietary Supplement: vitamin D3 (cholecalciferol); Other: olive oil; Dietary Supplement: calcium carbonate |
| placebo every three months | Placebo comparator | Not described Receives: Other: olive oil; Dietary Supplement: calcium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L
Measured: 12 months (including 9 time points)
Secondary outcomes (6)
Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline
Measured: 12 months (including 9 timepoints)
Hypercalciuria (dU-Ca >10 mmol/24h)
Measured: 12 months (including 9 timepoints)
Hypercalcemia (S-Ca-ion >1,3 mmol/l)
Measured: 12 months (including 9 timepoints)
Serum PTH
Measured: 12 months (including 9 timepoints)
Serum PINP
Measured: 12 months (including 5 timepoints)
Serum CTX
Measured: 12 months (including 5 timepoints)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypovitaminosis DStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ville-Valtteri Välimäki, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067898
- Sponsor's protocol ID
- HUS-S-D-II
- Other IDs
- 2009-018139-98, KLnro 1/2010, 2009
- Status last verified
- Mar 2012
- First submitted
- 11 Feb 2010
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pekkarinen T, Valimaki VV, Aarum S, Turpeinen U, Hamalainen E, Loyttyniemi E, Valimaki MJ. The same annual dose of 292000 IU of vitamin D (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D concentrations and renal function. Clin Endocrinol (Oxf). 2010 Apr;72(4):455-61. doi: 10.1111/j.1365-2265.2009.03637.x. Epub 2009 May 25.
PubMed 19486025Valimaki VV, Loyttyniemi E, Valimaki MJ. Vitamin D fortification of milk products does not resolve hypovitaminosis D in young Finnish men. Eur J Clin Nutr. 2007 Apr;61(4):493-7. doi: 10.1038/sj.ejcn.1602550. Epub 2006 Nov 29.
PubMed 17136043Valimaki VV, Alfthan H, Lehmuskallio E, Loyttyniemi E, Sahi T, Stenman UH, Suominen H, Valimaki MJ. Vitamin D status as a determinant of peak bone mass in young Finnish men. J Clin Endocrinol Metab. 2004 Jan;89(1):76-80. doi: 10.1210/jc.2003-030817.
PubMed 14715830
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months
- ClinicalTrials.gov ID
- NCT01067898
- Acronym / sponsor ID
- HUS-S-D-II
- Conditions
- Hypovitaminosis D
- Keywords
- vitamin D supplementation, cholecalciferol, PTH, bone turnover markers, elderly women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Feb 2010 (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 is to determine if infrequent administration of oral vitamin D megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin D3 in every three months would be effective and safe treatment to achieve the target levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200 000 IU vitamin D3 every three months | Experimental | Dietary Supplement: vitamin D3 (cholecalciferol), Dietary Supplement: calcium carbonate |
| 100 000 IU vitamin D3 every three months | Experimental | Dietary Supplement: vitamin D3 (cholecalciferol), Other: olive oil, Dietary Supplement: calcium carbonate |
| placebo every three months | Placebo comparator | Other: olive oil, Dietary Supplement: calcium carbonate |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- female
- 70-80 yrs old
Key exclusion criteria (2 listed)
- disease or medication affecting calcium homeostasis
- renal failure (Pt-GFRe-CG < 35 ml/min)
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)Also: Vigantol vitamin D3 (cholecalciferol) oil 20 000 IU/mlvitamin D3 (cholecalciferol) oil 20 000 IU/ml, oral dose of 200 000 IU or 100 000 IU (10ml or 5ml) every three months for one year. | Dietary supplement | 100 000 IU vitamin D3 every three months, 200 000 IU vitamin D3 every three months |
| olive oil10 ml (placebo group) or 5 ml (100 000 IU vitamin D3 group) oil per os every three months for one year | Other | 100 000 IU vitamin D3 every three months, placebo every three months |
| calcium carbonate1000 mg calcium per os every day for one year | Dietary supplement | 100 000 IU vitamin D3 every three months, 200 000 IU vitamin D3 every three months, placebo every three months |
Primary outcome
Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L
Time frame: 12 months (including 9 time points)
6 secondary outcomes
Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline
Time frame: 12 months (including 9 timepoints)
Hypercalciuria (dU-Ca >10 mmol/24h)
Time frame: 12 months (including 9 timepoints)
Hypercalcemia (S-Ca-ion >1,3 mmol/l)
Time frame: 12 months (including 9 timepoints)
Serum PTH
Time frame: 12 months (including 9 timepoints)
Serum PINP
Time frame: 12 months (including 5 timepoints)
Serum CTX
Time frame: 12 months (including 5 timepoints)
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 27 Mar 2012.
- Background: PubMed 19486025Pekkarinen T, Valimaki VV, Aarum S, Turpeinen U, Hamalainen E, Loyttyniemi E, Valimaki MJ. The same annual dose of 292000 IU of vitamin D (cholecalciferol) on either daily or four monthly basis for elderly women: 1-year comparative study of the effects on serum 25(OH)D concentrations and renal function. Clin Endocrinol (Oxf). 2010 Apr;72(4):455-61. doi: 10.1111/j.1365-2265.2009.03637.x. Epub 2009 May 25.
- Background: PubMed 17136043Valimaki VV, Loyttyniemi E, Valimaki MJ. Vitamin D fortification of milk products does not resolve hypovitaminosis D in young Finnish men. Eur J Clin Nutr. 2007 Apr;61(4):493-7. doi: 10.1038/sj.ejcn.1602550. Epub 2006 Nov 29.
- Background: PubMed 14715830Valimaki VV, Alfthan H, Lehmuskallio E, Loyttyniemi E, Sahi T, Stenman UH, Suominen H, Valimaki MJ. Vitamin D status as a determinant of peak bone mass in young Finnish men. J Clin Endocrinol Metab. 2004 Jan;89(1):76-80. doi: 10.1210/jc.2003-030817.
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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.
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?
A Phase 4 study testing vitamin D3 (cholecalciferol), olive oil and calcium carbonate in people with Hypovitaminosis D, run by Helsinki University Central Hospital 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 2 inclusion and 2 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 27 Mar 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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(OH)D3 concentration in relation to the target levels of 50-75 nmol/L (time frame: 12 months (including 9 time points)). 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 NCT01067898, which also lists 3 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 27 Mar 2012.