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The influence of a dietary advice on subclinical hypthyroidism in children, a randomised controlled trial


- candidate number21859
- NTR NumberNTR5138
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mrt-2015
- Secondary IDs52712 / NL 52712.044.15 ABR-nummer
- Public TitleThe influence of a dietary advice on subclinical hypthyroidism in children, a randomised controlled trial
- Scientific TitleThe influence of a dietary advice consisting of green vegetables, beef and whole dairy products on subclinical hypothyroidism in children, a randomised controlled trial
- ACRONYM
- hypothesisTo 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 1-18 years with subclinical hypothyroidism.
- Healt Condition(s) or Problem(s) studiedSubclinical hypothyroidism, Children
- Inclusion criteria 1. Age is 1-18 years
2. Diagnosis of subclinical hypothyroidism by pediatrician
3. Understanding of Dutch language by parents
- Exclusion criteria1. Clinical hypothyroidism (FT4 < 10pmol/L)
2. Treatment with levothyroxine
3. Immunological deficiencies
4. Cow’s milk allergy
5. Known or suspected disorder of intestinal absorption (e.g. celiac disease)
6. Disorders requiring a special diet
7. Any relevant congenital abnormality, anatomical abnormality, chromosomal disorder or severe disease
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2015
- planned closingdate1-jun-2017
- Target number of participants60
- InterventionsThe investigational product is a nutrient rich dietary advice consisting of green vegetables, beef and whole dairy products.
- Primary outcomeTSH levels
- Secondary outcome- Influence the tiredness
- decrease the anti-TPO
- influence the body mass index (BMI)
- influence the lipid profile
- Timepointst=0, 3 months and 6 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESkinderarts van der Gaag
- CONTACT for SCIENTIFIC QUERIESkinderarts van der Gaag
- Sponsor/Initiator Ziekenhuisgroep Twente, Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Ziekenhuisgroep Twente, Medisch Spectrum Twente
- Publicationshttp://www.scirp.org/journal/Articles.aspx?searchCode=gaag&searchField=All&page=1
- Brief summaryRationale: Subclinical hypothyroidism is a common disorder in early 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, increased cardiovascular risk, and 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 metabolic syndrome and other complications can be achieved. There are no randomised controlled trials that have investigated the effects of a dietary change in children. The only known RCT’s have been performed in adult populations.
Study population: Children aged 1-18 years with a diagnosis of subclinical hypothyroidism (TSH> 4,2 mU/l and normal FT4 values).
Main study parameters/endpoints: The main study parameter is the TSH-level. Secondary endpoints are lipid profile, BMI and tiredness.
- Main changes (audit trail)
- RECORD25-mrt-2015 - 30-apr-2015


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