Serum Sclerostin Level & Treatment of Vitamin D Deficiency

Vitamin D Deficiency Clinical Trial

— OMSOST  

Official title:

Serum Sclerostin Level in Patients With Vitamin D Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553344
• Other study ID #: BEAH FTR -7
• Status: Completed
• Phase: N/A
• First received: March 12, 2012
• Last updated: December 22, 2014
• Start date: March 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2014
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endocrine System Diseases
• Vitamin D Deficiency

Locations

Country	Name	City	State
Turkey	Bagcilar Training & Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum sclerostin level	Changes in serum sclerostin level in patients with osteomalacia who are scheduled for routine treatment of osteomalacia	8 weeks	No