NCT00957879

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

1.3 years

First QC Date

August 11, 2009

Last Update Submit

April 18, 2012

Conditions

Vitamin D Deficiency

Keywords

Vitamin DFGF23FGF-23Phosphate

Outcome Measures

Primary Outcomes (1)

  • Change in FGF23 levels

    12 weeks

Secondary Outcomes (3)

  • Change in serum phosphate

    12 weeks

  • Change in urinary phosphate

    12 weeks

  • Change in serum calcium

    12 weeks

Study Arms (2)

ergocalciferol

ACTIVE COMPARATOR

Weekly ergocalciferol for 12 weeks

Dietary Supplement: Ergocalciferol

calcitriol

ACTIVE COMPARATOR

Daily calcitriol for 12 weeks

Dietary Supplement: Calcitriol

Interventions

ErgocalciferolDIETARY_SUPPLEMENT

Ergocalciferol 50000 international units by mouth weekly for 12 weeks

ergocalciferol
CalcitriolDIETARY_SUPPLEMENT

Calcitriol 0.5 mcg by mouth daily for 12 weeks

calcitriol

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • 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. doi: 10.1359/jbmr.060507.

    PMID: 16869716BACKGROUND

  • Bhan I, Shah A, Holmes J, Isakova T, Gutierrez O, Burnett SM, Juppner H, Wolf M. Post-transplant hypophosphatemia: Tertiary 'Hyper-Phosphatoninism'? Kidney Int. 2006 Oct;70(8):1486-94. doi: 10.1038/sj.ki.5001788. Epub 2006 Aug 30.

    PMID: 16941023BACKGROUND

  • 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. doi: 10.1016/j.bone.2006.10.016. Epub 2006 Dec 8.

    PMID: 17157573BACKGROUND

  • Burnett-Bowie SM, 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 Oct;24(10):1681-5. doi: 10.1359/jbmr.090406.

    PMID: 19419295BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

ErgocalciferolsCalcitriol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsDihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferol

Study Officials

  • Sherri-Ann M Burnett-Bowie, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 13, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

US(1)