To evaluate whether a dietary advice of green vegetables, beef and whole dairy products during six months including standard supportive care can decrease the TSH-level compared to standard supportive care alone in children aged 1-12 years with…
ID
Source
Brief title
Condition
- Thyroid gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are (measured with venapunction at 0,3 and 6 months):
- TSH-level (measurement with electro-chemiluminescence sandwich immunoassay on
a COBAS 6000 (Roche Diagnostics)).
Secondary outcome
- Anti-TPO (venapunction at 0 and 6 months)
- Length and weight (at 0, 3 and 6 months)
- Tiredness questionnaire, age-dependent for 2-4y, 5-7y, 8-12y and 13-18y
(recorded by Pediatric QoL Multidimensional Fatigue Scale, Mapi Research Trust)
- Lipid profile (which includes; Total cholesterol, HDL, LDL, chol:HDL ratio,
triglycerides) (venapunction at 0, 3 and 6 months).
Other study parameters:
Parents will receive a questionnaire with various baseline characteristics
(e.g. ethnicity, social environment, gestational age, birth weight)
Background summary
Subclinical hypothyroidism is a common disorder in childhood. At the moment
there is no suitable therapy. However, several studies claim subclinical
hypothyroidism can have serious consequences. At first it can progress to overt
hypothyroidism, but secondly en probably more important, it is associated with
metabolic syndrome, an increased cardiovascular risk, an elevated cholesterol
and triglycerides, and an increased risk of depression, anxiety and panic
attacks in adulthood. Recent studies suggest a beneficial effect of dietary
advice consisting of green vegetables, beef and whole dairy products on the
TSH-level. This is important, because in this way prevention of development of
the metabolic syndrome and other complications can be achieved. There are no
randomised controlled trials that investigated the effects of this treatment in
children. The only known RCT*s are performed in adult populations.
Study objective
To evaluate whether a dietary advice of green vegetables, beef and whole dairy
products during six months including standard supportive care can decrease the
TSH-level compared to standard supportive care alone in children aged 1-12
years with subclinical hypothyroidism. Secondary goals are to assess whether
treatment with the dietary advice and standard supportive care compared to
standard supportive care alone will influence anti-TPO levels, the lipid
profile and the body mass index.
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
5 times a week green vegetables, 3 times a week beef, >300 mL whole milk a day,
whole butter on bread every day. Portion sizes are age appropriate.
Study burden and risks
Participation in the study is risk-free. A non-complex dietary advice as
treatment to alleviate the burden of children and parents regarding subclinical
hypothyroidism, a second venapunction and a small time investment for the extra
follow-up consult are regarded as mild burden of participation. The first and
second consult are part of the standard care, the third consult is an extra
follow up consult on behalf of the study. The peak incidence of subclinical
hypothyroidism is in early childhood and in teenagers and this state can have
serious early and late consequences, justifying the choice of treatment group
aged 1-12 years.
Haaksbergerstraat 55
Enschede 7513 ER
NL
Haaksbergerstraat 55
Enschede 7513 ER
NL
Listed location countries
Age
Inclusion criteria
1. Age 1-12 years
2. Diagnosis of subclinical hypothyroidism by paediatrician
3. Understanding of Dutch language by parents.
Exclusion criteria
1. Clinical hypothyroidism (FT4 < 10pmol/L)
2. Treatment with levothyroxine
3. Immunological deficiencies
4. Obesity (BMI > 25)
5. Diabetes Mellitus type 1
6. Cow*s milk allergy.
7. Known or suspected disorder of intestinal absorption (e.g. celiac disease).
8. Disorders requiring a special diet.
9. Any relevant congenital abnormality, anatomical abnormality, chromosomal 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 | NL52712.044.15 |
| Other | NTR volgt |