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A double-blind, placebo-controlled, crossover trial of soy phytoestrogens in patients with compensated hypothyroidism
DOI 10.1186/ISRCTN55827330
ClinicalTrials.gov identifier
EudraCT number
Public title A double-blind, placebo-controlled, crossover trial of soy phytoestrogens in patients with compensated hypothyroidism
Scientific title
Acronym SOPHY
Serial number at source T05029
Study hypothesis In patients with compensated hypothyroidism , the defined soy protein/isoflavone preparation will cause a further elevation of thyroid stimulating hormone with a concomitant fall in thyroxine.
Lay summary
Ethics approval Hull and East Riding Local Research Ethics Committee on 02/09/2004, (ref: LREC/03/04/044); REC also gave a favourable ethical opinion on 13/02/06 for the extension of an additional study site in York
Study design Double-blind, placebo-controlled crossover trial
Countries of recruitment United Kingdom
Disease/condition/study domain Compensated hypothyroidism
Participants - inclusion criteria Patients with newly diagnosed compensated hypothyroidism (thyroid stimulating hormone [TSH] >4.7 and normal T4)
Participants - exclusion criteria 1. Patients on thyroxine or drugs that interfere with thyroid function
2. Patients who have had antibiotics within 3 months of starting the trial
3. Patients not wishing to allow disclosure to their general practitioners (GPs)
Anticipated start date 10/04/2006
Anticipated end date 10/02/2007
Status of trial Completed
Patient information material
Target number of participants 134
Interventions Soy protein alone versus soy protein with isoflavone in patients with
compensated hyperthyroidism
Primary outcome measure(s) Change in thyroid stimulating hormone (TSH) and thyroxine levels as in hypothesis
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Food Standards Agency
Trial website
Publications 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21325465
Contact name Prof  Stephen  Atkin
  Address Michael White Diabetes Centre

220-236 Anlaby Road
  City/town Hull
  Zip/Postcode HU3 2RW
  Country United Kingdom
  Tel +44 (0)1482 675365
  Fax +44 (0)1482 675370
  Email s.l.atkin@hull.ac.uk
Sponsor Hull and East Yorkshire Hospitals Trust (UK)
  Address Anlaby Road
  City/town Hull
  Zip/Postcode HU2 3JZ
  Country United Kingdom
Date applied 05/04/2006
Last edited 28/04/2011
Date ISRCTN assigned 09/05/2006
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