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Completed

NCT Number: NCT01553344

Serum Sclerostin Level & Treatment of 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.

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Key information

Conditions

Endocrine System Diseases Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Deficiency Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteomalacia Rickets Sclerosteosis Vitamin D Deficiency

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Bagcilar Training & Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Serum sclerostin level

    Time frame: 8 weeks

    Changes in serum sclerostin level in patients with osteomalacia who are scheduled for routine treatment of osteomalacia

Sponsors and collaborators

Lead sponsor

Bagcilar Training and Research Hospital

Other Gov

Registry information

Official study title

Serum Sclerostin Level in Patients With Vitamin D Deficiency

Acronym: OMSOST

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2012
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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