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Different Vitamin D Preparations & FGF23 in Humans

Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitamin D Deficiency

Intervention: Ergocalciferol (Dietary Supplement); Calcitriol (Dietary Supplement)

Phase: N/A

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Sherri-Ann M Burnett-Bowie, MD, MPH, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Sherri-Ann M Burnett-Bowie, MD, MPH, Phone: 617-724-5594, Email: sburnett-bowie@partners.org

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 disease. In this study the investigators are investigating the effects of different forms of vitamin D on FGF23 levels in the blood in order to increase our understanding of how this important hormone works.

Clinical Details

Official title: Effect of Different Vitamin D Preparations on Circulating FGF23 Levels in Vitamin D Deficient Caucasian and African-American Men and Women

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Change in FGF23 levels

Secondary outcome:

Change in serum phosphate

Change in urinary phosphate

Change in serum calcium

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 induced osteomalacia (TIO) are 3 rare diseases characterized by rickets/osteomalacia, fractures, and hypophosphatemia secondary to renal phosphate wasting and inappropriately low levels of activated vitamin D (calcitriol), which are caused by excess amounts of or mutated FGF23. FGF23 excess also occurs in renal failure, where elevated FGF23 levels predict increased mortality. Thus, abnormal FGF23 appears to be central to both rare and common diseases. While FGF23 appears to be regulated by vitamin D, dietary and serum phosphate, much is still unknown. The effects of different forms of vitamin D on FGF23 stimulation are not well characterized. Similarly, any racial differences in the regulation of FGF23 by vitamin D have not been investigated.

To address these knowledge deficits, we will randomize 52 vitamin D deficient (25OHD < or = 24 ng/mL by LC/MS) Caucasian and African-American men and women to treatment with either dietary vitamin D or activated vitamin D for 12 weeks. Our primary endpoint will be the change in FGF23 with dietary versus activated vitamin D.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Sherri-Ann M Burnett-Bowie, MD, MPH, Phone: 617-724-5594, Email: sburnett-bowie@partners.org

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Additional Information

Related publications:

Burnett SM, Gunawardene SC, Bringhurst FR, Juppner H, Lee H, Finkelstein JS. Regulation of C-terminal and intact FGF-23 by dietary phosphate in men and women. J Bone Miner Res. 2006 Aug;21(8):1187-96.

Bhan I, Shah A, Holmes J, Isakova T, Gutierrez O, Burnett SM, J├╝ppner H, Wolf M. Post-transplant hypophosphatemia: Tertiary 'Hyper-Phosphatoninism'? Kidney Int. 2006 Oct;70(8):1486-94. Epub 2006 Aug 30.

Burnett-Bowie SM, Mendoza N, Leder BZ. Effects of gonadal steroid withdrawal on serum phosphate and FGF-23 levels in men. Bone. 2007 Apr;40(4):913-8. Epub 2006 Dec 8.

Burnett-Bowie SA, Henao MP, Dere ME, Lee H, Leder BZ. Effects of hPTH(1-34) Infusion on Circulating Serum Phosphate, 1,25-Dihydroxyvitamin D and FGF23 Levels in Healthy Men. J Bone Miner Res. 2009 May 6; [Epub ahead of print]

Starting date: May 2009
Last updated: April 30, 2010

Page last updated: December 08, 2011

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