Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/04/2006
Date assigned
09/05/2006
Last edited
28/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

Michael White Diabetes Centre
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom
+44 (0)1482 675365
s.l.atkin@hull.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

T05029

Study information

Scientific title

Acronym

SOPHY

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Compensated hypothyroidism

Intervention

Soy protein alone versus soy protein with isoflavone in patients with
compensated hyperthyroidism

Intervention type

Drug

Phase

Not Specified

Drug names

Soy protein with isoflavone

Primary outcome measures

Change in thyroid stimulating hormone (TSH) and thyroxine levels as in hypothesis

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/04/2006

Overall trial end date

10/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with newly diagnosed compensated hypothyroidism (thyroid stimulating hormone [TSH] >4.7 and normal T4)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

134

Participant 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)

Recruitment start date

10/04/2006

Recruitment end date

10/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Michael White Diabetes Centre
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospitals Trust (UK)

Sponsor details

Anlaby Road
Hull
HU2 3JZ
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Food Standards Agency

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21325465

Publication citations

  1. Results

    Sathyapalan T, Manuchehri AM, Thatcher NJ, Rigby AS, Chapman T, Kilpatrick ES, Atkin SL, The effect of soy phytoestrogen supplementation on thyroid status and cardiovascular risk markers in patients with subclinical hypothyroidism: a randomized, double-blind, crossover study., J. Clin. Endocrinol. Metab., 2011, 96, 5, 1442-1449, doi: 10.1210/jc.2010-2255.

Additional files

Editorial Notes