Vitamin D DeficiencyPhase 4NCT01025128
Vitamin D Status in Males in Jerusalem Area and Its Correlation to Parathyroid Hormone (PTH) Level and Bone Mineral Density
A Phase 4 study testing 25 OH vitamin D in people with Vitamin D Deficiency and Secondary Hyperparathyroidism, run by Clalit Health Services at 1 site in Israel.
Trial summary
Because of its high sun exposure, Israel was traditionally supposed to be protected from vitamin D deficiency, and the country food products hardly contain vitamin D supplements. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Secondary Hyperparathyroidism, Osteomalacia
- What is being tested?
- 25 OH vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Jul 2014
- 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects aged 18-70
- If age below 40 must not be under any chronic medication
Who cannot join
- Medication: anti-convulsivants, non-topical steroids (past or present), anti-rejection medications
- Malabsorptive diseases (Crohn's disease, cystic fibrosis,Whipple' disease, s/p bariatric surgery)
- Morbid obesity (BMI above 35)
- Rheumatoid arthritis
- Liver failure
- Nephrotic syndrome
Show all 15Show fewer
- Chronic kidney disease
- Genetic disorder
- Malignancy
- Primary hyperparathyroidism
- Granulomatous disease
- Hyperthyroidism
- Nephrolithiasis (present or past)
- S/P skin grafts surgery
- Mental disorder or cognitive disorder
Trial locations and contacts
1 site in 1 country.
About this study
Because of its high sun exposure, Israel was traditionally supposed to be protected from vitamin D deficiency, and the country food products hardly contain vitamin D supplements. However the Jerusalem ultra-Orthodox population, which constitutes a significant fraction of the city population, is at risk of developing vitamin D deficiency due to low sun exposure, as consequence of its dressing code covering most of the body and very limited time of outside activities. The investigators aim is to check whether vitamin D deficiency is found more frequently in the ultra-Orthodox male population in comparison to a non-ultra-Orthodox male population, and to study its eventual consequences. Correlation between vitamin D levels and PTH levels will be examined, according to age and to creatinine levels. Bone mineral density (BMD) will be evaluated in 2 selected subgroups of subjects (with lowest and highest vitamin D levels), and re-evaluated after 6 months of vitamin D supplementation in vitamin D-deficient subjects. An increase in BMD within 6 months would suggest osteomalacia as the main cause of low BMD in these subjects.
Read the detailed description
Subjects:
The study will include 200 males aged 18-70, living in the Jerusalem area. Enrollment will be distributed among 8 clinics of the Clalit Health Services: 4 clinics located in predominantly ultra-Orthodox areas (group A) and 4 clinics located in mixed areas (Group B).
Each group of clinics will enroll 100 subjects as sub-defined:
Age 18-24: 30 patients (Groups A1 and B1) Age 25-39: 30 patients (Groups A2 and B2) Age 40-54: 20 patients (Groups A3 and B3) Age 55-70: 20 patients (Groups A4 and B4)
Study protocol:
Enrollment will be performed by the physicians participating in the study and the nurses working in the corresponding clinics, after advertisement of the study in the clinics.
Visit 1:
- The subjects will receive information about the study aims and protocol and will sign an informed consent form.
- Blood pressure, height and weight will be measured and BMI calculated.
- The subjects will fill a questionnaire concerning their personal habits: dressing code, degree of sun exposure, physical activity, smoking, alcohol consumption, muscular pains and general fatigue.
- The physician (co-investigator) signing the informed consent form will rule out subjects presenting pre-defined exclusion criteria.
- Blood samples will be drawn for: calcium, phosphorus, PTH, 25 OH Vitamin D, 1,25 OH Vitamin D, magnesium, creatinine, alkaline phosphatase, albumin.
- A urine sample will be collected for magnesium and calcium/creatinine ratio.
The subjects will receive the lab results by mail, with a recommendation to consult their family physician in order to receive treatment in case of vitamin D deficiency. (Vitamin D levels <20 ng/ml)
The subjects in the 18-39 age groups (Groups A1, A2, B1 and B2) will be classified according to their vitamin D levels. The 20 subjects presenting the highest vitamin D levels or with vitamin D level>30 ng/ml will constitute the "high D" group and the 40 subjects with the lowest vitamin D levels will constitute the "low D" group. (We expect the vitamin D levels to be above 30 ng/ml in the "high D" group and below 10 ng/ml in the "low D" groups, according to the results of our pilot study).
Subjects with vitamin D level>30 ng/ml or <10 ng/ml can be enrolled to the 60 patients of the "high D" and "low D " groups and will proceed to visits 2 and 3.
Visit 2:
60 subjects (20 from the "high D" group and 40 from the "low D" group) will undergo a bone mineral density examination in the Osteoporosis Center of Mount-Scopus Hadassah Hospital. All subjects with low vitamin D levels will receive a 6-month vitamin D supplementation of 2000 units per day for the first 12 weeks and of 1000 units per day for the next 12 weeks.
Visit 3:
The 60 subjects who underwent visit 2 will undergo visit 3 six months later.
- The subjects will fill a questionnaire similar to the first one and detail their degree of compliance with vitamin D supplementation
- Blood samples will be drawn for plasma levels of: calcium, phosphorus, magnesium, PTH, 25 OH vitamin D, 1,25 (OH)2 vitamin D, creatinine, alkaline phosphatase, albumin
- A urine sample will be collected for magnesium and calcium/creatinine ratio.
- A repeat bone mineral density examination will be performed in the Osteoporosis Center Mount-Scopus Hadassah Hospital
The subjects will receive their test results by mail with a recommendation to consult their family physician in case of persistent abnormal results.
- Being tested
- 25 OH vitamin D
- Medical subject headings
- Vitamin D Deficiency, Hyperparathyroidism, Secondary, Osteomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25 OH vitamin DDrug
oral supplementation of 25 OH vitamin D at dose of 2000 units/d for 3 months then 1000 units/d for 3 months
| Study group | Role | What they receive |
|---|---|---|
| group A low D | Active comparator | ultra-Orthodox clinics patients aged 18-39 with lowest vitamin D levels Receives: Drug: 25 OH vitamin D |
| group A high D | No intervention | ultra-Orthodox clinics patients aged 18-39 with highest vitamin D levels |
| group B low D | Active comparator | mixed population clinics patients aged 18-39 with lowest vitamin D levels Receives: Drug: 25 OH vitamin D |
| group B high D | No intervention | mixed population clinics patients aged 18-39 with highest vitamin D levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma vitamin D level
Measured: 6 months
Secondary outcomes (3)
bone mineral density before vitamin D supplementation
Measured: 8 months
plasma PTH level
Measured: 6 months
bone mineral density after vitamin D supplementation in vitamin D deficient subjects
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJul 2014
- Study completionJul 2014
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 4
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metzger Muriel, Clalit Health Services
- Investigators
- Muriel Metzger, MD, Principal investigator, Clalit Health Services, Jerusalem, IsraelAnat Tsur, MD, Principal investigator, Clalit Health Services, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025128
- Sponsor's protocol ID
- K129/09
- Status last verified
- Jul 2014
- First submitted
- 1 Dec 2009
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status in Males in Jerusalem Area and Its Correlation to Parathyroid Hormone (PTH) Level and Bone Mineral Density
- ClinicalTrials.gov ID
- NCT01025128
- Acronym / sponsor ID
- K129/09
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Dec 2009 (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.
Because of its high sun exposure, Israel was traditionally supposed to be protected from vitamin D deficiency, and the country food products hardly contain vitamin D supplements. However the Jerusalem ultra-Orthodox population, which constitutes a significant fraction of the city population, is at risk of developing vitamin D deficiency due to low sun exposure, as consequence of its dressing code covering most of the body and very limited time of outside activities. The investigators aim is to check whether vitamin D deficiency is found more frequently in the ultra-Orthodox male population in comparison to a non-ultra-Orthodox male population, and to study its eventual consequences. Correlation between vitamin D levels and PTH levels will be examined, according to age and to creatinine levels. Bone mineral density (BMD) will be evaluated in 2 selected subgroups of subjects (with lowest and highest vitamin D levels), and re-evaluated after 6 months of vitamin D supplementation in vitamin D-deficient subjects. An increase in BMD within 6 months would suggest osteomalacia as the main cause of low BMD in these subjects.
Detailed description
Subjects:
The study will include 200 males aged 18-70, living in the Jerusalem area. Enrollment will be distributed among 8 clinics of the Clalit Health Services: 4 clinics located in predominantly ultra-Orthodox areas (group A) and 4 clinics located in mixed areas (Group B).
Each group of clinics will enroll 100 subjects as sub-defined:
Age 18-24: 30 patients (Groups A1 and B1) Age 25-39: 30 patients (Groups A2 and B2) Age 40-54: 20 patients (Groups A3 and B3) Age 55-70: 20 patients (Groups A4 and B4)
Study protocol:
Enrollment will be performed by the physicians participating in the study and the nurses working in the corresponding clinics, after advertisement of the study in the clinics.
Visit 1:
- The subjects will receive information about the study aims and protocol and will sign an informed consent form.
- Blood pressure, height and weight will be measured and BMI calculated.
- The subjects will fill a questionnaire concerning their personal habits: dressing code, degree of sun exposure, physical activity, smoking, alcohol consumption, muscular pains and general fatigue.
- The physician (co-investigator) signing the informed consent form will rule out subjects presenting pre-defined exclusion criteria.
- Blood samples will be drawn for: calcium, phosphorus, PTH, 25 OH Vitamin D, 1,25 OH Vitamin D, magnesium, creatinine, alkaline phosphatase, albumin.
- A urine sample will be collected for magnesium and calcium/creatinine ratio.
The subjects will receive the lab results by mail, with a recommendation to consult their family physician in order to receive treatment in case of vitamin D deficiency. (Vitamin D levels <20 ng/ml)
The subjects in the 18-39 age groups (Groups A1, A2, B1 and B2) will be classified according to their vitamin D levels. The 20 subjects presenting the highest vitamin D levels or with vitamin D level>30 ng/ml will constitute the "high D" group and the 40 subjects with the lowest vitamin D levels will constitute the "low D" group. (We expect the vitamin D levels to be above 30 ng/ml in the "high D" group and below 10 ng/ml in the "low D" groups, according to the results of our pilot study).
Subjects with vitamin D level>30 ng/ml or <10 ng/ml can be enrolled to the 60 patients of the "high D" and "low D " groups and will proceed to visits 2 and 3.
Visit 2:
60 subjects (20 from the "high D" group and 40 from the "low D" group) will undergo a bone mineral density examination in the Osteoporosis Center of Mount-Scopus Hadassah Hospital. All subjects with low vitamin D levels will receive a 6-month vitamin D supplementation of 2000 units per day for the first 12 weeks and of 1000 units per day for the next 12 weeks.
Visit 3:
The 60 subjects who underwent visit 2 will undergo visit 3 six months later.
- The subjects will fill a questionnaire similar to the first one and detail their degree of compliance with vitamin D supplementation
- Blood samples will be drawn for plasma levels of: calcium, phosphorus, magnesium, PTH, 25 OH vitamin D, 1,25 (OH)2 vitamin D, creatinine, alkaline phosphatase, albumin
- A urine sample will be collected for magnesium and calcium/creatinine ratio.
- A repeat bone mineral density examination will be performed in the Osteoporosis Center Mount-Scopus Hadassah Hospital
The subjects will receive their test results by mail with a recommendation to consult their family physician in case of persistent abnormal results.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group A low D | Active comparator | Drug: 25 OH vitamin Dultra-Orthodox clinics patients aged 18-39 with lowest vitamin D levels |
| group A high D | No intervention | –ultra-Orthodox clinics patients aged 18-39 with highest vitamin D levels |
| group B low D | Active comparator | Drug: 25 OH vitamin Dmixed population clinics patients aged 18-39 with lowest vitamin D levels |
| group B high D | No intervention | –mixed population clinics patients aged 18-39 with highest vitamin D levels |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male subjects aged 18-70
- If age below 40 must not be under any chronic medication
Key exclusion criteria (15 listed)
- Medication: anti-convulsivants, non-topical steroids (past or present), anti-rejection medications
- Malabsorptive diseases (Crohn's disease, cystic fibrosis,Whipple' disease, s/p bariatric surgery)
- Morbid obesity (BMI above 35)
- Rheumatoid arthritis
- Liver failure
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 |
|---|---|---|
| 25 OH vitamin Doral supplementation of 25 OH vitamin D at dose of 2000 units/d for 3 months then 1000 units/d for 3 months | Drug | group A low D, group B low D |
Primary outcome
plasma vitamin D level
Time frame: 6 months
3 secondary outcomes
bone mineral density before vitamin D supplementation
Time frame: 8 months
plasma PTH level
Time frame: 6 months
bone mineral density after vitamin D supplementation in vitamin D deficient subjects
Time frame: 13 months
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 21 Jul 2014.
Related trials for Vitamin D Deficiency
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
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.
Muriel Metzger, MD principal investigator
Clalit Health Services, Jerusalem, Israel
Anat Tsur, MD principal investigator
Clalit Health Services, Jerusalem, Israel
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 25 OH vitamin D in people with Vitamin D Deficiency and Secondary Hyperparathyroidism, run by Clalit Health Services 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 2 inclusion and 15 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 21 Jul 2014. 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 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?
plasma vitamin D level (time frame: 6 months). 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 Jul 2014.