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CompletedNCT01102751Updated Apr 13, 2010

Serum FGF-23 and Vitamin D Deficiency

An observational study in Osteomalacia, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 9 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-04-13.

Sponsored by Istanbul University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Ages
9 Years to 44 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Osteomalacia

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Keywords

  • fibroblast growth factor 23
  • Osteomalacia
  • vitamin D
03

In context

Osteomalacia

34 studies on the registry are indexed under Osteomalacia; 3 are open to participants now.

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Lead sponsor

Istanbul University is the lead sponsor of 511 studies on the registry; 78 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

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04

Who can participate

Ages eligible
9 Years to 44 Years
Sexes eligible
All
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.

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Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Receiving medication(s) affecting bone metabolism
  • History of gastrointestinal disease and malabsorption
  • History of renal and liver disease
05

Study design

Observational model
Case-control
Time perspective
Prospective

Groups and 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)

06

Study locations

1 site
  • Istanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Endocrinology and Metabolism
    Istanbul, 34390, Turkey
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01102751
First posted
Apr 13, 2010
Last update
Apr 13, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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