NCT01025128

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

4.5 years

First QC Date

December 1, 2009

Last Update Submit

July 18, 2014

Conditions

Vitamin D DeficiencySecondary HyperparathyroidismOsteomalacia

Outcome Measures

Primary Outcomes (1)

  • plasma vitamin D level

    6 months

Secondary Outcomes (3)

  • bone mineral density before vitamin D supplementation

    8 months

  • plasma PTH level

    6 months

  • bone mineral density after vitamin D supplementation in vitamin D deficient subjects

    13 months

Study Arms (4)

group A low D

ACTIVE COMPARATOR

ultra-Orthodox clinics patients aged 18-39 with lowest vitamin D levels

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

Drug: 25 OH vitamin D

group B high D

NO INTERVENTION

mixed population clinics patients aged 18-39 with highest vitamin D levels

Interventions

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

group A low Dgroup B low D

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male subjects aged 18-70
  • If age below 40 must not be under any chronic medication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology Clinic, Clalit Health Services

Jerusalem, Israel

Location

MeSH Terms

Conditions

Vitamin D DeficiencyHyperparathyroidism, SecondaryOsteomalacia

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesHyperparathyroidismParathyroid DiseasesEndocrine System DiseasesRicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesCalcium Metabolism Disorders

Study Officials

  • Muriel Metzger, MD

    Clalit Health Services, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

  • Anat Tsur, MD

    Clalit Health Services, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 3, 2009

Study Start

January 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations

IL(1)