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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37787683

Enrollment

Registered

2010-03-10

Start date

2010-04-01

Completion date

Unknown

Last updated

2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome Nutritional, Metabolic, Endocrine Ovarian dysfunction

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026