A double-blind, placebo-controlled, crossover trial of soy phytoestrogens in patients with compensated hypothyroidism
| ISRCTN | ISRCTN55827330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55827330 |
| Protocol serial number | T05029 |
| Sponsor | Hull and East Yorkshire Hospitals Trust (UK) |
| Funder | Food Standards Agency |
- 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
Scientific
Michael White Diabetes Centre
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom
| Phone | +44 (0)1482 675365 |
|---|---|
| s.l.atkin@hull.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind, placebo-controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Soy protein with isoflavone |
| Primary outcome measure(s) |
Change in thyroid stimulating hormone (TSH) and thyroxine levels as in hypothesis |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 10/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Michael White Diabetes Centre
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
