Serum Sclerostin Level & Treatment of Vitamin D Deficiency

NCT01553344 — Completed, 26 participants, Bagcilar Training and Research Hospital

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Serum Sclerostin Level in Patients With Vitamin D Deficiency

RegistryNCT01553344, acronym OMSOST
StatusCompleted
Study typeObservational
Enrollment26 (Actual)
SponsorBagcilar Training and Research Hospital (Other gov)
ConditionsEndocrine System Diseases, Vitamin D Deficiency
Datesstart 2012-03-01, primary completion 2013-04-01, completion 2013-11-01, first posted 2012-03-14, last updated 2014-12-23
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Endocrine System Diseases All trials for Vitamin D Deficiency

-Summary

The aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with Vitamin D deficiency treated with calcium and vitamin D.

Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with calcium and vitamin D will be included in the study. This is an observational study. The serum sclerostin levels will be measured before and after Vitamin D treatment.

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+Detailed description

This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board.

This study will be completed with patients with Vitamin D deficiency. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained before and after treatment.

Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of serum will be added to eppendorf tubes and stored at -20°C.

Serum sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically <0.012 ng/ml. Intra-assay precision is less than 8%.

+Outcome measures

Primary outcomes

  • Serum sclerostin level [8 weeks]: Changes in serum sclerostin level in patients with osteomalacia who are scheduled for routine treatment of osteomalacia

+Eligibility

Sex: Female, ages: 20 Years to 50 Years

Inclusion Criteria:

* Premenopausal
* Serum 25(OH)D < 10 ng/mL

Exclusion Criteria:

* Anemia
* Tumor-induced osteomalacia (hypophosphatemia)
* Hypothyroidism
* Hepatic / renal disease
* Primary hyperparathyroidism
* Fibromyalgia
* Polymyalgia rheumatica
* Serum 25(OH)D > 10 ng/mL
* Vitamin D and calcium treatment commenced prior to study participation

+Locations (1)

FacilityCityCountryStatus
Bagcilar Training & Research HospitalIstanbulTurkey (Türkiye)

+Investigators

  • MUHARREM CIDEM, MD, Principal investigator, Bagcilar Training & Research Hospital Istanbul, Turkey