A treatment method of a dietary advice of green vegetables, beef and whole dairy products during twelve months including standard supportive care can decrease the number and duration of upper respiratory tract infections compared to standard…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the number of infections in six months and the
number of days a month with symptoms of URTI, which is calculated as the mean
of the number of days with symptoms a month of paediatrician diagnosed URTI in
the previous three months.
Secondary outcome
Secondary goals are to assess whether treatment with the dietary advice and
standard supportive care compared to standard supportive care alone will
influence immunoglobulin levels, decrease number of days absence of child from
day-care, decrease number of days absence of parents from work, decrease the
number of prescribed antibiotics and a decrease in total cholesterol:HDL-ratio.
Background summary
Rationale: Recurrent upper respiratory tract infections are a common problem
with a great number of days with illness for young children. At the moment
there is no suitable treatment for patients with an idiopathic cause of
recurrent URTI. This can lead to an increased burden in parental concern and
productivity, as well as maintaining a certain degree unnecessary prescription
of antibiotics. Recent studies suggest a beneficial effect of dietary advice
consisting of green vegetables, beef and whole dairy products on the number of
days with symptoms. There are no randomised controlled trials that investigated
the effects of this treatment.
Study objective
A treatment method of a dietary advice of green vegetables, beef and whole
dairy products during twelve months including standard supportive care can
decrease the number and duration of upper respiratory tract infections compared
to standard supportive care alone in children aged 1-4 years with recurrent
upper respiratory tract infections.
Study design
A multicentre randomised controlled trial will be performed, with an
intervention group receiving standard supportive care plus the dietary advice
and a control group receiving standard supportive care alone.
Intervention
A dietary advice: 5 times a week green vegetables, 3 times a week beef, 300 mL
whole milk a day, whole butter on bread. Portion sizes are age appropriate.
Study burden and risks
The only risk above the risk of every day life is one extra venapunction, the
other procedures are considered to be risk-free. The dietary advice is not
complex and hardly a burden. The peak incidence of URTI in children is in the
first 5 years of life, justifying the choice of treatment group aged 1-4 years.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
Inclusion criteria
Age 1-4 years.
Recurrent URTI (>3 in 3 months).
Understanding of Dutch language (parents).
Exclusion criteria
Immunological deficiencies.
Cow's milk allergy.
Known or suspected disorder of intestinal absorption.
Prophylactic use of antibiotics.
Disorders requiring a special diet.
Any relevant congenital abnormality, chormosomal disorder or severe disease.
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 | NL50373.044.14 |
| Other | nummer volgt/Nederlands Trial Register |