The influence of a dietary advice consisting of green vegetables, beef and whole dairy products on subclinical hypothyroidism in children, a randomised controlled trial

Completed

Conditions: impaired thyroid function
Subclinical hypothyroidism
10043739

Registration Number: NL-OMON47234

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are (measured with venapunction at 0,3 and 6 months):<br /><br>- TSH-level (measurement with electro-chemiluminescence sandwich immunoassay on<br /><br>a COBAS 6000 (Roche Diagnostics)). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Anti-TPO (venapunction at 0 and 6 months)<br /><br>- Length and weight (at 0, 3 and 6 months)<br /><br>- Tiredness questionnaire, age-dependent for 2-4y, 5-7y, 8-12y and 13-18y<br /><br>(recorded by Pediatric QoL Multidimensional Fatigue Scale, Mapi Research Trust)<br /><br>- Lipid profile (which includes; Total cholesterol, HDL, LDL, chol:HDL ratio,<br /><br>triglycerides) (venapunction at 0, 3 and 6 months).<br /><br><br /><br>Other study parameters:<br /><br>Parents will receive a questionnaire with various baseline characteristics<br /><br>(e.g. ethnicity, social environment, gestational age, birth weight)</p><br>