Vitamin D DeficiencyPhase 3NCT00640237
Interventional Trial of Vitamin D Deficiency in the Patients of General Departments
A Phase 3 study testing Alpha-D3 in people with Vitamin D Deficiency, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of the study is to examine the vitamin D state of elder patients in therapeutic departments and to compere the treatment during the hospitalization with the out-patient treatment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Alpha-D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2008to Aug 2008
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- the patient was admitted to a general department of Rambam Medical Center for any reason from March to May 2008
- the patient is 65 years old or older
- the patient is in a good health, based on medical history, physical examination and laboratory screening evaluation.
Who cannot join
- renal failure with creatinine level more then 1.3 mg/dL or nephritic syndrome.
- liver disease with transaminase rise three times from normal level.
- nephrolithiasis in the last fife years.
- primary hyperparathyroidism, hypoparathyroidism or pseudohypoparathyroidism.
- advanced cancer.
- chronic diarrhea or malabsorption.
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- granulomatous disease (sarcoidosis, tuberculosis, lymphoma).
- patients, who are receiving barbiturates, rifampin, anticonvulsants.
- patients, who are receiving digitalis.
- patients, who are receiving glucocorticoids for more than two weeks during the study.
- advanced dementia.
Trial locations and contacts
1 site in 1 country.
Nodelmam Marina, MD contact
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa
Nodelman Marina, MD
About this study
Official title: Vitamin D Deficiency in the Elder Patients of General Departments and Its Treatment During the Hospitalization
The purpose of the study is to examine the vitamin D state of elder patients in therapeutic departments and to compere the treatment during the hospitalization with the out-patient treatment.
Read the detailed description
Today vitamin D is thought to be one of the most important vitamins in the human body. It's made in the skin during the sun expose, so it must be sufficient in so sunny countries as Israel. Although many old people in our country suffer from vitamin d deficiency which bring them to recurrent falls, osteoporotic fractures and physical disability. This problem is still underestimated by health authorities in different countries.
In this study we will examine the vitamin D state of the therapeutic patient older than 65 year including their physical self-estimation, muscle strength measurement and gait-and-balance tests. Then, according to the resent studies, we will treat the patients in the interventional group with two large doses of vitamin D during a month. After that we will compere their health and physical state with the patients treated in the out-hospital department.
So we will try to find a useful approach to treat the vitamin D deficiency during the hospitalization.
- Conditions
- Vitamin D Deficiency
- Being tested
- Alpha-D3
- Keywords
- Vitamine D State
- 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.
Alpha-D3Dietary supplement
Also called 25(OH)-D3
We will use the vitamin alpha-D3 drops of CTS pharmaceutical firm , that contains 5000 IU in ml. Every patient in the interventional group will receive two dose of 100000 IU (20 ml)vitamin alpha-D3 within a month period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm 1 - the patients will receive two large doses of vitamin D. Receives: Dietary Supplement: Alpha-D3 |
| 2 | No intervention | Arm 2 - the patients vitamin D status will be checked during the hospitalization and they will receive the recommendation to treat the vitamin D deficiency in the out-patient department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D status
Measured: two month
Secondary outcomes (1)
physical performance, health conditions, arm strength, gait and balance state.
Measured: two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2008 (estimated)
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Ish-Shalom Sofia, Professor, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640237
- Sponsor's protocol ID
- VD-1.CTIL
- Status last verified
- Mar 2008
- First submitted
- 16 Mar 2008
- Last updated
- 21 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency in the Elder Patients of General Departments and Its Treatment During the Hospitalization
- ClinicalTrials.gov ID
- NCT00640237
- Acronym / sponsor ID
- VD-1.CTIL
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamine D State
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 21 Mar 2008 (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 the study is to examine the vitamin D state of elder patients in therapeutic departments and to compere the treatment during the hospitalization with the out-patient treatment.
Detailed description
Today vitamin D is thought to be one of the most important vitamins in the human body. It's made in the skin during the sun expose, so it must be sufficient in so sunny countries as Israel. Although many old people in our country suffer from vitamin d deficiency which bring them to recurrent falls, osteoporotic fractures and physical disability. This problem is still underestimated by health authorities in different countries.
In this study we will examine the vitamin D state of the therapeutic patient older than 65 year including their physical self-estimation, muscle strength measurement and gait-and-balance tests. Then, according to the resent studies, we will treat the patients in the interventional group with two large doses of vitamin D during a month. After that we will compere their health and physical state with the patients treated in the out-hospital department.
So we will try to find a useful approach to treat the vitamin D deficiency during the hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Alpha-D3Arm 1 - the patients will receive two large doses of vitamin D. |
| 2 | No intervention | –Arm 2 - the patients vitamin D status will be checked during the hospitalization and they will receive the recommendation to treat the vitamin D deficiency in the out-patient department. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- the patient was admitted to a general department of Rambam Medical Center for any reason from March to May 2008
- the patient is 65 years old or older
- the patient is in a good health, based on medical history, physical examination and laboratory screening evaluation.
Key exclusion criteria (11 listed)
- renal failure with creatinine level more then 1.3 mg/dL or nephritic syndrome.
- liver disease with transaminase rise three times from normal level.
- nephrolithiasis in the last fife years.
- primary hyperparathyroidism, hypoparathyroidism or pseudohypoparathyroidism.
- advanced cancer.
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 |
|---|---|---|
| Alpha-D3Also: 25(OH)-D3We will use the vitamin alpha-D3 drops of CTS pharmaceutical firm , that contains 5000 IU in ml. Every patient in the interventional group will receive two dose of 100000 IU (20 ml)vitamin alpha-D3 within a month period. | Dietary supplement | 1 |
Primary outcome
vitamin D status
Time frame: two month
1 secondary outcome
physical performance, health conditions, arm strength, gait and balance state.
Time frame: two month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2008.
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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.
Nodelmam Marina, MD contact
Ish-Shalom Sofia, Professor principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alpha-D3 in people with Vitamin D Deficiency, run by Rambam Health Care Campus at 1 site in Israel.
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 11 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: status not confirmed, as of the sponsor's last update on 21 Mar 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 Israel. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ish-Shalom Sofia, Professor (0502061099, s_ish_shalom@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vitamin D status (time frame: two month). 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 21 Mar 2008.