A double-blind, placebo-controlled, crossover trial of soy phytoestrogens in patients with compensated hypothyroidism

ISRCTN	ISRCTN55827330
DOI	https://doi.org/10.1186/ISRCTN55827330
Secondary identifying numbers	T05029

Submission date: 05/04/2006
Registration date: 09/05/2006
Last edited: 30/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stephen Atkin
Scientific

Michael White Diabetes Centre
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom

Phone	+44 (0)1482 675365
Email	s.l.atkin@hull.ac.uk

Study information

Study design	Double-blind, placebo-controlled crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	A double-blind, placebo-controlled, crossover trial of soy phytoestrogens in patients with compensated hypothyroidism
Study acronym	SOPHY
Study objectives	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.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	Compensated hypothyroidism
Intervention	Soy protein alone versus soy protein with isoflavone in patients with compensated hyperthyroidism
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Soy protein with isoflavone
Primary outcome measure	Change in thyroid stimulating hormone (TSH) and thyroxine levels as in hypothesis
Secondary outcome measures	Not provided at time of registration
Overall study start date	10/04/2006
Completion date	10/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	134
Total final enrolment	60
Key inclusion criteria	Patients with newly diagnosed compensated hypothyroidism (thyroid stimulating hormone [TSH] >4.7 and normal T4)
Key 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)
Date of first enrolment	10/04/2006
Date of final enrolment	10/02/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Michael White Diabetes Centre

Hull
HU3 2RW
United Kingdom

Sponsor information

Hull and East Yorkshire Hospitals Trust (UK)
Hospital/treatment centre

Anlaby Road
Hull
HU2 3JZ
England
United Kingdom

Email	abc@email.com
"ROR"	https://ror.org/01b11x021

Funders

Funder type

Government

Food Standards Agency
Private sector organisation / Other non-profit organizations

Alternative name(s): The Food Standards Agency, FSA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2011		Yes	No
Other publications	follow-up analysis	11/04/2019		Yes	No

Editorial Notes

30/04/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
30/04/2019: Publication reference added.