Vitamin D Status in Males in Jerusalem Area and Its Correlation to Parathyroid Hormone (PTH) Level and Bone Mineral Density - Full Text View

Purpose

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.

Condition	Intervention	Phase
Vitamin D Deficiency Secondary Hyperparathyroidism Osteomalacia	Drug: 25 OH vitamin D	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary hypophosphatemic rickets

MedlinePlus related topics: Bone Density Minerals Vitamin D

Drug Information available for: Vitamin D

Genetic and Rare Diseases Information Center resources: Osteomalacia Rickets

U.S. FDA Resources

Further study details as provided by Clalit Health Services:

Primary Outcome Measures:

plasma vitamin D level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

bone mineral density before vitamin D supplementation [ Time Frame: 8 months ] [ Designated as safety issue: No ]
plasma PTH level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
bone mineral density after vitamin D supplementation in vitamin D deficient subjects [ Time Frame: 13 months ] [ Designated as safety issue: No ]


Enrollment:	210
Study Start Date:	January 2010
Study Completion Date:	July 2014
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: group A low D ultra-Orthodox clinics patients aged 18-39 with lowest vitamin D levels	Drug: 25 OH vitamin D 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	Drug: 25 OH vitamin D 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

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Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025128

Locations


Israel
Endocrinology Clinic, Clalit Health Services
Jerusalem., Israel

Sponsors and Collaborators

Clalit Health Services

Investigators


Principal Investigator:	Muriel Metzger, MD	Clalit Health Services, Jerusalem, Israel
Principal Investigator:	Anat Tsur, MD	Clalit Health Services, Jerusalem, Israel

More Information


Responsible Party:	Metzger Muriel, MD, Clalit Health Services
ClinicalTrials.gov Identifier:	NCT01025128 History of Changes
Other Study ID Numbers:	K129/09
Study First Received:	December 1, 2009
Last Updated:	July 18, 2014
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:


Hyperparathyroidism Vitamin D Deficiency Hyperparathyroidism, Secondary Osteomalacia Parathyroid Diseases Endocrine System Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Rickets Bone Diseases, Metabolic	Bone Diseases Musculoskeletal Diseases Calcium Metabolism Disorders Metabolic Diseases Vitamins Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 23, 2016