Objective of this study is to study the influence of phosphate intake on FGF23 blood levels, in order to understand kinetics of FGF23 in relation to phosphate intake.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
het gaat om gezonde proefpersonen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
FGF23 serum concentration, during the period of phosphate restriction and the
period of high phosphate intake.
Secondary outcome
not applicable
Background summary
Fibroblast Growth Factor 23 (FGF23) is a relatively unknown protein which is
involved in phosphatemetabolism. It is known that FGF23 serum concentration is
elevated in patients suffering from chronical kidney disease (CKD). This
elevation of FGF23 serum concentration seems to be associated with
hyperphosphotemia existing in these patients. In the future FGF23 might be an
important marker to diagnose latently present hyperphosphatemia early in CKD,
in order to start treatment with phosphate binders at an earlier stage. This
might be associated with a slower decline of renal function in these patients,
and/or early ameliorate 1,25 dihydroxycholecalciferol deficiency, since FGF23
inhibits 1alpha-hydroxylase.
Study objective
Objective of this study is to study the influence of phosphate intake on FGF23
blood levels, in order to understand kinetics of FGF23 in relation to phosphate
intake.
Study design
On day 1 there will be a baseline examination of FGF23 serum concentration
during the day as well as creatinine, calcium, phosphate and PTH, urea,
albumin, 25(OH)vitamin D3 and 1.25(OH)2 vitamin D3. The blood samples will be
taken in the morning (fasting) (T= 0), before lunch (T=4) and before dinner
(T=8). Breakfast and lunch are as usual, dinner has to be phosphate restricted
on day 1. After the first blood collection of day 1, the 24h- urine collection
starts. The collected urine will be examined on natrium, kalium, calcium,
phosphate, creatinine, urea and total protein excretion.
On day 2 the diet is phosphate restricted. This day another three blood samples
are taken: T=0 (fasting, before phosphate restricted breakfast), T= 4 (before
phosphate restricted lunch) and T= 8 (before phosphate restricted dinner).
After the first blood collection of day 2, the 24h- urine collection starts.
The blood samples will be examined as described above.
In the morning of day 3 there shall be another blood collection and the
collected urine will be examined as described above.
Day 4 until day 7 the diet is as usual.
On day 8 until day 10 the same procedure is repeated; the only difference is
that the phosphate intake will be high this time.
Study burden and risks
the test person has be compliant to a diet during two times one and a half day,
he has to collect his urine for four days and a total amount of 14 bloodsamples
will be taken.
postbus 7057
1007 MB Amsterdam
Nederland
postbus 7057
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
healthy adults (> 18 years)
Exclusion criteria
smoking, pregnancy and a serum creatinine level > 100 micromol/liter
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23674.029.08 |