No registrations found.
ID
Source
Health condition
children with subclinical hypothyroidism
Sponsors and support
Medisch spectrum Twente
Intervention
Outcome measures
Primary outcome
TSH levels
Secondary outcome
- Influence the tiredness
- decrease the anti-TPO
- influence the body mass index (BMI)
- influence the lipid profile
Background summary
Rationale: 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.
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 1-18 years with subclinical hypothyroidism.
Study design
t=0, 3 months and 6 months
Intervention
The investigational product is a nutrient rich dietary advice consisting of green vegetables, beef and whole dairy products.
Inclusion criteria
1. Age is 1-18 years
2. Diagnosis of subclinical hypothyroidism by pediatrician
3. Understanding of Dutch language by parents
Exclusion criteria
1. 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
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 |
|---|---|
| NTR-new | NL4891 |
| NTR-old | NTR5138 |
| Other | ABR-nummer : 52712 / NL 52712.044.15 |