Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187629
Status:
COMPLETED
Last Update Posted:
2013-10-09
First Post:
2005-09-13
Brief Title:
Phosphate Intakes Effect on the Skeletal System - Pilot
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Phosphate Intakes Effect on the Skeletal System Calcitropic Hormones and FGF23 - Pilot Study
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the effects of different amounts of phosphorus in the diet on hormones that control phosphorus and bone health both in men who are healthy and in ones who have moderate kidney disease
Detailed Description:
Chronic kidney disease affects 11 of the US population over half of those affected have skeletal manifestations of their renal disease Renal osteodystrophy is a complex disease in which multiple mineral systems and related hormones play a role including phosphate homeostasis Phosphate regulation primarily depends on renal handling of phosphate which is partly controlled by parathyroid hormone and vitamin D However other mediators in this system clearly exist Recently evidence has been accruing that one such factor may be FGF23 a protein produced by osteogenic cells States of excess FGF23 are associated with marked phosphate wasting hypophosphatemia osteomalacia and inappropriately low calcitriol FGF23 levels are measurable in healthy humans and markedly elevated in patients who require hemodialysis although its physiologic role in either state is unknown Some retrospective evidence suggests that FGF23 is affected by phosphate intake We are performing a pilot study to gather preliminary data describing the response of FGF23 to changes in dietary phosphorus intake in healthy men and in men with moderate renal insufficiency The specific aims of this pilot study are 1 To examine the physiologic effects of alterations in dietary phosphorus on FGF23 in healthy subjects 2 To examine the physiologic response of FGF23 to dietary phosphorus alterations in patients with moderate renal failure 3 To assess whether serum levels of 125-dihydroxyvitamin D vary inversely with those of FGF23 when dietary phosphate is changed 4 To determine the temporal pattern of calcitropic hormones and FGF23 in response to dietary phosphate changes and 5 To determine the variability of the changes in serum FG 23 in response to dietary phosphate manipulations The proposed research plan is a dietary intervention trial in which we will study the response of serum FGF23 levels to diets with varying phosphorus contents in healthy adults and adults with moderate renal insufficiency
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None