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
A double-blind, placebo-controlled, crossover trial of soy phytoestrogens in patients with compensated hypothyroidism
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 measure
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 (if study stopped)
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
Total final enrolment
60
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
-
abc@email.com
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Food Standards Agency
Alternative name(s)
FSA
Funding Body Type
unknown
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21325465
2019 follow-up analysis in: https://www.ncbi.nlm.nih.gov/pubmed/31031706
Publication citations
-
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.