Status:
COMPLETED
Different Vitamin D Preparations & FGF23 in Humans
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Fibroblast growth factor 23 (FGF23) is a new hormone which controls phosphate and vitamin D levels in humans. Excess FGF23 is associated with an increased risk of death in patients with chronic kidney...
Detailed Description
Fibroblast growth factor 23 (FGF23) is a novel hormone involved in phosphate and vitamin D physiology. X-linked hypophosphatemia (XLH), autosomal dominant hypophosphatemic rickets (ADHR), and tumor in...
Eligibility Criteria
Inclusion
- Age 18 to 45 yrs
- Serum 25OHD \< 24 ng/mL by liquid chromatography/mass spectroscopy
- At least 1 menses in the last 3 months (females) and normal serum testosterone (males)
- African-American or Caucasian race
Exclusion
- Significant cardiac, hepatic, oncologic, or psychiatric disease
- History of malabsorption, kidney stones, or recent alcohol excess/abuse
- Use of medications known to affect serum phosphate levels including phosphate-binding antacids, sodium etidronate, calcitonin, excessive doses of vitamin D (\> 1000 units per day), excessive doses of vitamin A (\> 20,000 units/day), calcitriol, growth hormone, or anti-convulsants
- Use of thiazide diuretics or cholestyramine
- Serum calcium \< 8 or \> 11 mg/dL, creatinine \> 1.5 mg/dL, or Hgb \< 11 gm/dL
- Serum glucose \>140mg/dL
- Liver function tests \> 2 times the upper limit of normal
- TSH \< 0.1 or \> 7 uU/mL
- WBC \< 2,000 or \> 15,000/cmm
- Platelet count \< 100,000 or \> 500,000/cum
- Hormone replacement therapy (however, oral contraceptives are allowed) or testosterone use
- Urine beta-hCG positive (females)
- Serum phosphate \> 4.6 mg/dL
- Allergy to vitamin D
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00957879
Start Date
May 1 2009
End Date
March 1 2011
Last Update
April 19 2012
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114