A Phase 4 interventional study of 25 OH vitamin D in Vitamin D Deficiency, Secondary Hyperparathyroidism and Osteomalacia, sponsored by Clalit Health Services. Completed at 1 site in Israel. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-21.
Sponsored by Clalit Health Services · Phase 4, Interventional, and Screening
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.
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 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 receive their test results by mail with a recommendation to consult their family physician in case of persistent abnormal results.
34 studies on the registry are indexed under Osteomalacia; 3 are open to participants now.
This study's enrollment of 210 is above the median of 15 across 17 interventional studies indexed under Osteomalacia.
Browse Osteomalacia studies →Clalit Health Services is the lead sponsor of 44 studies on the registry; none are open to participants now.
Compared within Osteomalacia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vitamin D Deficiency. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ultra-Orthodox clinics patients aged 18-39 with lowest vitamin D levels
Drug: 25 OH vitamin D
ultra-Orthodox clinics patients aged 18-39 with highest vitamin D levels
mixed population clinics patients aged 18-39 with lowest vitamin D levels
Drug: 25 OH vitamin D
mixed population clinics patients aged 18-39 with highest 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
plasma vitamin D level
Time frame: 6 months
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
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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