NCT01102751

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
Last Updated

April 13, 2010

Status Verified

August 1, 2009

First QC Date

April 12, 2010

Last Update Submit

April 12, 2010

Conditions

Keywords

fibroblast growth factor 23Osteomalaciavitamin D

Study Arms (3)

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)

Eligibility Criteria

Age9 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Endocrinology and Metabolism

Istanbul, 34390, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteomalacia

Condition Hierarchy (Ancestors)

RicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 13, 2010

Last Updated

April 13, 2010

Record last verified: 2009-08

Locations