Research with human participants

Overview of medical research in the Netherlands

Distal renal tubular acidosis in Sjögren syndrome

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Last updated:

The objectives of this study are to determine the prevalence of dRTA, osteoporosis and nephrolithiasis in patients with SS. We also try to elucidate the mechanism which is responsible for developing dRTA in patients with SS. The role of auto…

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Autoimmune disorders
Study type
Observational invasive

ID

NL-OMON39423

Source

ToetsingOnline

Brief title

dRTA by Sjögren syndrome

Condition

  • Autoimmune disorders
  • Nephropathies

Synonym

renal tubular acidosis

Research involving

Human

Sponsors and support

Primary sponsor :
Erasmus MC, Universitair Medisch Centrum Rotterdam
Source(s) of monetary or material Support :
eigen middelen + kleine subsidie Kolff beurs

Intervention

Keyword :
acidification test, calcium metabolism, dRTA, Sjögren syndrome

Outcome measures

Primary outcome

The presence of dRTA and/or disorders in calcium metabolism and if present the

underlying pathogenetic mechanism.

Secondary outcome

not applicable

Background summary

Sjögren syndrome (SS) is associated with distal renal tubular acidosis (dRTA).
The true prevalence of dRTA in patients with SS is unclear. dRTA is associated
with osteoporosis and kidney stone formation and a poor well-being of the
patient. There is an effective treatment for dRTA so screening for dRTA in
patients with SS is necessary.

Study objective

The objectives of this study are to determine the prevalence of dRTA,
osteoporosis and nephrolithiasis in patients with SS. We also try to elucidate
the mechanism which is responsible for developing dRTA in patients with SS. The
role of auto antibodies against carbonic anhydrasis type II and the M3-receptor
will be considered.

Study design

The study is an observational study. All participants will be hospitalized
during a half day.

Study burden and risks

There are no risks for the participant by participating this study. There are
no adverse events described by the used urinary acidification test.

Public
Erasmus MC, Universitair Medisch Centrum Rotterdam

's Gravendijkwal 230
Rotterdam 3015CE
NL
Scientific
Erasmus MC, Universitair Medisch Centrum Rotterdam

's Gravendijkwal 230
Rotterdam 3015CE
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Patients fullfilling the criteria of the Revised International classification criteria for Sjögren syndrome with Sjögren syndrome
A healthy controlgroup
Age >20 years

Exclusion criteria

Hypokalemia prior to the test
Age < 20 years

Design

Study type :
Observational invasive
Intervention model
:
Other
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Basic science

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
97
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

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 NL37422.078.11