To determine if cardiovascular risk indices including postprandial hypertriglyceridaemia are modified favourably by nicotinic acid (niacin) in patients with polycystic ovary syndrome (PCOS)

ISRCTN	ISRCTN37787683
DOI	https://doi.org/10.1186/ISRCTN37787683
ClinicalTrials.gov (NCT)	NCT01118598
Protocol serial number	N/A
Sponsor	Hull and East Yorkshire Hospital NHS Trust (UK)
Funders	Hull and East Yorkshire Hospital NHS Trust (UK) - Research and Development Department, Merck, Sharp & Dohme Corp. (UK) - supplies study medicine (Tredaptive® and placebo)

Submission date: 05/02/2010
Registration date: 10/03/2010
Last edited: 13/02/2020

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

Department of Diabetes, Endocrinology and Metabolism
Hull York Medical School
Michael White Diabetes Centre
Hull Royal Infirmary
Hull
HU3 2RW
United Kingdom

Phone	+44 (0)1482 675 365
Email	stephen.atkin@hyms.ac.uk

Study information

Primary study design	Interventional
Study design	Single-centre randomised double-blind placebo-controlled parallel trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	To determine if cardiovascular risk indices including postprandial hypertriglyceridaemia are modified favourably by nicotinic acid (niacin) in patients with polycystic ovary syndrome (PCOS): a randomised double-blind placebo-controlled parallel study
Study objectives	Niacin will improve postprandial hyperlipidaemia and cardiovascular risks indices via its lipid lowering as well as via pleiotrophic effects in patients with polycystic ovary syndrome (PCOS).
Ethics approval(s)	Leeds (East) Research Ethics Committee, 21/01/2010, ref: 09/H1306/103
Health condition(s) or problem(s) studied	Polycystic ovary syndrome
Intervention	Patients will be allocated as 1:1 ratio to the intervention group and the placebo group. For the first 4 weeks, participants will take orally either one tablet of nicotinic acid 1000 mg/laropiprant 20 mg (Tredaptive®) or one tablet of placebo per day. If patient tolerates it, the dose will be increased to either two tablets of nicotinic acid 1000 mg/laropiprant 20 mg (Tredaptive®) or two tablets of placebo per day from week 5 to week 12. Total duration of treatment is 12 weeks and total duration of follow-up is up to 2 weeks after the end of intervention.
Intervention type	Drug
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Niacin, laropiprant (Tredaptive®)
Primary outcome measure(s)	To determine if the dyslipidaemic cardiovascular risk indices including postprandial hypertriglyceridaemia are reversed favourably by nicotinic acid (niacin) therapy. Blood tests will be done at baseline, at week 5 and at week 9 and at the completion of the intervention for both groups.
Key secondary outcome measure(s)	1. To determine the effect of nicotinic acid on insulin resistance and other markers of cardiovascular risk such as high sensitivity c-reactive protein (hsCRP) 2. To determine the effect of nicotinic acid on endothelial function Blood tests will be done at baseline, at week 5 and at week 9 and at the completion of the intervention for both groups. Endothelial function test will be done at baseline and at the end of the study.
Completion date	01/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	36
Key inclusion criteria	1. Females aged between 18 - 50 years 2. Has polycystic ovary syndrome diagnosed according to Rotterdam consensus statement (to meet two out of three criteria after exclusion of other endocrine disorders): 2.1. Patient has oligomenorrhoea (less than nine cycles per year)/anovulation 2.2. Patient has evidence of clinical/biochemical hyperandrogenism 2.3. Patient has polycystic ovaries on trans-vaginal ultrasound
Key exclusion criteria	1. Pregnancy/trying to conceive/breastfeeding 2. History of cardiovascular, renal, hepatic and active thyroid disease 3. History of gout 4. History of alcohol abuse 5. History of diabetes 6. History of allergy to nicotinic acid/laropiprant or food 7. History of bleeding disorders/active peptic ulcers 8. Patient on antihypertensive medications 9. Patient on anticoagulants 10. Patient on any hormonal replacement or oral contraceptive pills or cholesterol-lowering agents 11. History of smoking more than 15 pack year 12. Unwilling for GP to be informed
Date of first enrolment	01/04/2010
Date of final enrolment	01/10/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Diabetes, Endocrinology and Metabolism

Hull
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	01/06/2014		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/02/2020: ClinicalTrials.gov number added.