Serum Sclerostin Level & Treatment of Vitamin D Deficiency (OMSOST)

December 22, 2014 updated by: Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital

Serum Sclerostin Level in Patients With Vitamin D Deficiency

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.

Study Overview

Status

Completed

Conditions

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%.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bagcilar Training & Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with vitamin D deficiency

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum sclerostin level
Time Frame: 8 weeks
Changes in serum sclerostin level in patients with osteomalacia who are scheduled for routine treatment of osteomalacia
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bagcilar Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (ESTIMATE)

March 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEAH FTR -7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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