Serum FGF-23 and Vitamin D Deficiency

This study has been completed.
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT01102751
First received: April 12, 2010
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

We aimed to determine the effect of vitamin D replacement therapy on serum FGF-23 concentrations in vitamin D deficient women and to compare the FGF-23 concentrations of vitamin D deficient patients with healthy subjects and patients with genetically-determined hypophosphatemic rickets.


Condition
Osteomalacia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects Of Vitamin D Replacement Therapy on Serum FGF-23 Concentrations in Vitamin D Deficient Women In Short Term

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Groups/Cohorts
Vitamin D deficient females
(n =18, mean age 29.1±9.9 yrs)
vitamin D sufficient healthy females
(control group; n = 19, mean age 28.5±5.2 yrs)
genetically-determined hypophosphatemic rahitis
(n=13, mean age 26.5±15.1 yrs)

Detailed Description:

Study group was composed of vitamin D deficient females (n =18, mean age 29.1±9.9 yrs), vitamin D sufficient healthy females (control group; n = 19, mean age 28.5±5.2 yrs) and patients with genetically-determined hypophosphatemic rickets (n=13, mean age 26.5±15.1 yrs). Groups were compared for serum FGF-23, 1,25 dihydroxy vitamin D3, calcium, phosphate, bone turnover markers, intact parathyroid hormone and urinary excretion of calcium and phosphate. Vitamin D deficient group was re-evaluated after a standard treatment regimen.

  Eligibility

Ages Eligible for Study:   9 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Group 1: Eighteen premenopausal female patients with a diagnosis of vitamin D deficient osteomalacia were included in this group. Vitamin D deficiency was diagnosed according to the serum 25 hydroxy vitamin D3 (25OHD) concentrations (< 30 ng/mL). Reasons for vitamin D deficiency were verified as insufficient exposure to sunlight, frequent parturition and prolonged lactation. All of these patients received a standard treatment regimen; oral Vitamin D3 150 000 IU once for all and subsequently 880 IU D3 and 1000 mg calcium carbonate for six weeks. This group was also evaluated after replacement therapy at sixth week.

Group 2: Nineteen healthy premenopausal women who had normal levels of serum 25OHD Vitamin (>30 ng/mL) composed the control group.

Group 3: Thirteen hypophosphatemic rickets (3 autosomal dominant and 10 X-linked; 9 female and 4 male) were included in this group.

Criteria

Inclusion Criteria:

  • Serum 25OHD Vitamin <30 ng/mL for group 1
  • Serum 25OHD Vitamin >30 ng/mL for control group

Exclusion Criteria:

  • Receiving medication(s) affecting bone metabolism
  • History of gastrointestinal disease and malabsorption
  • History of renal and liver disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01102751

Locations
Turkey
Istanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Endocrinology and Metabolism
Istanbul, Turkey, 34390
Sponsors and Collaborators
Istanbul University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01102751     History of Changes
Other Study ID Numbers: Istanbul University, Research Fund
Study First Received: April 12, 2010
Last Updated: April 12, 2010
Health Authority: Turkey: Ethics Committee

Keywords provided by Istanbul University:
fibroblast growth factor 23
Osteomalacia
vitamin D

Additional relevant MeSH terms:
Osteomalacia
Vitamin D Deficiency
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014