Optimal Vitamin D AdministrationNCT00575835
Oral Vitamin D Supplementation in Elderly Women
A study testing vitamin D twice daily and Vitamin D3 oil three times in a year in people with Optimal Vitamin D Administration, run by University of Helsinki at 1 site in Finland.
Trial summary
The aim of this study is to compare oral vitamin D supplementation administered in two different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily supplementation of calcium 1 gram. Read more about this study
- Who is it for?
- Ages 70 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Optimal Vitamin D Administration
- What is being tested?
- vitamin D twice daily and Vitamin D3 oil three times in a year
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2006to Oct 2007
- 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 70 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Females
- 70-80 years
- Living in the community
Who cannot join
- Renal disease
- Diseases that contraindicate vitamin D supplementation
- Medications affecting bone
- Malignancy
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital, department of medicine, division of endocrinology
Helsinki, 00029 HUS
About this study
Official title: Oral Vitamin D Supplementation in Elderly Women: Twice a Day or Three Times a Year? A Randomised Controlled Trial
The aim of this study is to compare oral vitamin D supplementation administered in two different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of 25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in vitamin D concentrations in these treatments. 3) Find out safety of these treatments
- Conditions
- Optimal Vitamin D Administration
- Being tested
- vitamin D twice daily, Vitamin D3 oil three times in a year
- Keywords
- vitamin D, seasonal variation, PTH, bone markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D twice dailyDietary supplement
Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year
Vitamin D3 oil three times in a yearDietary supplement
Vigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Dietary Supplement: vitamin D twice daily |
| 2 | Experimental | Not described Receives: Dietary Supplement: Vitamin D3 oil three times in a year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood 25 OH D vitamin concentrations
Measured: 8 times during the year
Secondary outcomes (1)
serum calcium, 24-hour calcium excretion in urine, creatinine clearance
Measured: 8 times during the year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startOct 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optimal Vitamin D AdministrationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Päivikki and Sakari Sohlberg Foundation, Finland, Lilly Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575835
- Sponsor's protocol ID
- 77/2006
- Status last verified
- Dec 2007
- First submitted
- 17 Dec 2007
- Last updated
- 8 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Vitamin D Supplementation in Elderly Women: Twice a Day or Three Times a Year? A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00575835
- Acronym / sponsor ID
- 77/2006
- Conditions
- Optimal Vitamin D Administration
- Keywords
- vitamin D, seasonal variation, PTH, bone markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Päivikki and Sakari Sohlberg Foundation, Finland, Lilly Foundation
- Study start
- Oct 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 18 Dec 2007 (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 aim of this study is to compare oral vitamin D supplementation administered in two different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of 25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in vitamin D concentrations in these treatments. 3) Find out safety of these treatments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: vitamin D twice daily |
| 2 | Experimental | Dietary Supplement: Vitamin D3 oil three times in a year |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Females
- 70-80 years
- Living in the community
Key exclusion criteria (4 listed)
- Renal disease
- Diseases that contraindicate vitamin D supplementation
- Medications affecting bone
- Malignancy
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 D twice dailyKalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year | Dietary supplement | 1 |
| Vitamin D3 oil three times in a yearVigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year | Dietary supplement | 2 |
Primary outcome
Blood 25 OH D vitamin concentrations
Time frame: 8 times during the year
1 secondary outcome
serum calcium, 24-hour calcium excretion in urine, creatinine clearance
Time frame: 8 times during the 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 8 Jan 2008.
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 study testing vitamin D twice daily and Vitamin D3 oil three times in a year in people with Optimal Vitamin D Administration, 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 3 inclusion and 4 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 8 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 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. 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?
Blood 25 OH D vitamin concentrations (time frame: 8 times during the year). 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 8 Jan 2008.