- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01025128
Vitamin D Status in Males in Jerusalem Area and Its Correlation to Parathyroid Hormone (PTH) Level and Bone Mineral Density
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Jerusalem., Israel
- Endocrinology Clinic, Clalit Health Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male subjects aged 18-70
- If age below 40 must not be under any chronic medication
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group A low D
ultra-Orthodox clinics patients aged 18-39 with lowest vitamin D levels
|
oral supplementation of 25 OH vitamin D at dose of 2000 units/d for 3 months then 1000 units/d for 3 months
|
No Intervention: group A high D
ultra-Orthodox clinics patients aged 18-39 with highest vitamin D levels
|
|
Active Comparator: group B low D
mixed population clinics patients aged 18-39 with lowest vitamin D levels
|
oral supplementation of 25 OH vitamin D at dose of 2000 units/d for 3 months then 1000 units/d for 3 months
|
No Intervention: group B high D
mixed population clinics patients aged 18-39 with highest vitamin D levels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasma vitamin D level
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
bone mineral density before vitamin D supplementation
Time Frame: 8 months
|
8 months
|
plasma PTH level
Time Frame: 6 months
|
6 months
|
bone mineral density after vitamin D supplementation in vitamin D deficient subjects
Time Frame: 13 months
|
13 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muriel Metzger, MD, Clalit Health Services, Jerusalem, Israel
- Principal Investigator: Anat Tsur, MD, Clalit Health Services, Jerusalem, Israel
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Endocrine System Diseases
- Nutrition Disorders
- Musculoskeletal Diseases
- Parathyroid Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases
- Bone Diseases, Metabolic
- Calcium Metabolism Disorders
- Rickets
- Hyperparathyroidism
- Vitamin D Deficiency
- Hyperparathyroidism, Secondary
- Osteomalacia
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Vitamin D
Other Study ID Numbers
- K129/09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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