- To evaluate the effect of magnesium and phosphate supplementation on intracellular levels of magnesium and phosphate determined with different techniques.- To determine if symptoms are related to intracellular levels of magnesium or phosphate.
ID
Source
Brief title
Condition
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intracellular levels of magnesium or phosphate in erythrocytes, peripheral
blood mononuclear cells and skeletal muscle before and after supplementation of
magnesium and phosphate
Secondary outcome
- Serum magnesium or phosphate
- Personalized symptom score sheet
- ATP levels in skeletal muscle cells (measured by 31P NMR)
Background summary
Magnesium and phosphate are electrolytes that mainly reside intracellularly.
Both electrolytes have an important intracellular role, they are for instance
involved in intracellular cell signalling and energy metabolism. The kidney is
an important regulator of magnesium and phosphate homeostasis. Disturbances in
this regulation can lead to renal wasting of magnesium or phosphate, causing
hypomagnesemia or hypophosphatemia.
Patients with renal hypomagnesemia and hypophosphatemia suffer from symptoms
such as fatigue, muscle weakness and paraesthesia. Treatment consists of
supplementation therapy. However, despite normalization or near normalization
of serum magnesium or phosphate, some patients remain symptomatic. This might
be because of a intracellular deficit of magnesium or phosphate. Serum
magnesium and phosphate are probably not a good parameter of depletion of
magnesium and phosphate.
We hypothesize that intracellular levels of magnesium, phosphate and/or
possibly ATP are better parameters for the assessment of magnesium and
phosphate depletion than serum levels. Also, we assume that symptoms are more
related to intracellular levels of magnesium and phosphate than serum levels.
Study objective
- To evaluate the effect of magnesium and phosphate supplementation on
intracellular levels of magnesium and phosphate determined with different
techniques.
- To determine if symptoms are related to intracellular levels of magnesium or
phosphate.
Study design
A pilot observational diagnostic test study
Study burden and risks
Patients will receive their regular treatment. Investigational tests will be
performed during regular outpatient clinic visits or during a planned regular
admission to our inpatient ward. An additional blood sample will be drawn when
a venapuncture was already scheduled in the context of regular treatment. A
MRI-scan will be performed, this is a non-invasive procedure without
complications. Also patients will have to fill out a personalized symptom
questionnaire.
Geert Grooteplein Zuid 8
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 8
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- Symptomatic renal hypomagnesemia or hypophosphatemia
- Patient is about to start with regular supplementation therapy (oral or
intravenous supplementation) or therapy is planned to be intensified based on
insufficient response on the previous treatment (increasing oral
supplementation or addition of intravenous supplementation on top of oral
supplementation)
- Age >= 16 years
- Informed consent
Exclusion criteria
- patients who are pregnant at time of inclusion
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 | NL72523.091.20 |