Phase 1:- The main objective of this phase of the study is to determine the variation of UAC over 8 weeks time in toddlers. - The secondary objective of this phase is to determine the variation of UAC over 3 days time.Phase 2:- The main objective of…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Phase 1: The coefficient of variation (CV) of UAC calculated over 8 weeks time.
Phase 2: The percentage babies and todders with a geometric mean of UAC>
20mg/L.
Secondary outcome
Phase 1: The CV of UAC calculated over 3 days
Phase 2: The correlation of log transformed UAC with several parameters
obtained from a questionnaire.
Background summary
Increased urinary albumin excretion (UAC) has been established as an important
determinant of renal and cardiovascular risk. A possible hypothesis is that an
increased albuminuria en thus an increased cardiovascular risk is caused by a
congenital variation and quality of the peripheral vasculature.
In recent studies, prevalence of increased albuminuria in the general
population of approximately 5 * 8% is found. A prevalence of approximately 7%
has been found in children of 20-40 months old. These data could support the
hypothesis.
However, these data are based on one single measurement. Little is known about
the day to day variation and the variation throughout the day of albuminuria in
children; is it a continuous value, or is an increased value an intercurrent
event?
Study objective
Phase 1:
- The main objective of this phase of the study is to determine the variation
of UAC over 8 weeks time in toddlers.
- The secondary objective of this phase is to determine the variation of UAC
over 3 days time.
Phase 2:
- The main objective of this phase is to determine the prevalence of
microalbuminuria in this study population.
- The secondary objective of this phase is to investigate the correlation of
several parameters of child and parents obtained from a questionnaire.
Study design
This is a prospective cohort study
Study burden and risks
No risk is associated with participation in this study. Only an amout of urine
samples will be collected. This is no burden for the children, but somehow for
the parents because they have to perform extra actions when changing the diaper.
When an abnormal high UAC (>200 mg/L) is found, parents will be informed.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- age 12-48 months
The inclusion of participants will be devided in two phases. In the first phase, 110 participants will be included, in which the variability of albuminuria will be studied. In the second phase an additional number of toddlers in the same age range will be included to determine the prevalence of microalbuminuria over the total study population. Once we know the day-to-day variability in albuminuria in this population we will be able to perform a powercalculation to determine the sample size for phase 2 of the study.
Exclusion criteria
- Known renal disease of the child
- Current infection of the urinary tract
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 | NL50374.042.14 |