Effect of Omega-3 Supplementation as Add on Therapy on Metabolic Syndrome in Women With Polycystic Ovary Syndrome: A Randomized Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Effect of Omega-3 Supplementation as Add on Therapy on Metabolic Syndrome in Women with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial
研究概览
简要总结
The goal of this clinical trial is to learn if Omega-3 works to treat Polycystic ovary syndrome in women. It will also learn about the safety of drug Omega-3. The main questions it aims to answer are:
Does Omega-3 lower the number of times participant to treat metabolic syndrome What medical problems do participants have when taking drug Omega-3.Researchers will compare drug Omega-3 to a placebo (a look-alike substance that contains no drug) to see if drug Omega-3 used to treat PCOS.
Participants will:
Take Omega-3 or a placebo every day for 3 months Visit the clinic once every 6 weeks for checkups and tests Keep a diary of their symptoms and menstrual history.
详细描述
This research will be a single center study, utilizing a double-blind, randomized placebo-controlled trial design. A total of 62 women, with newly diagnosed PCOS, age range from 18-36 years will randomly be assigned to receive either Omega-3 supplementation (1gm twice daily) or a placebo for 12 weeks. Biochemical and anthropometric measurements, including lipid profile, fasting blood sugar, blood pressure, inflammatory markers (CRP) and body composition such as BMI, waist circumference will be assessed at baseline and post-intervention. Follow-up assessments will be conducted three months after supplementation to evaluate the sustainability of metabolic changes. For independent samples; t-test will be utilized to analyze the average differences in metabolic biomarker levels between the group receiving Omega-3 supplements and the group receiving a placebo. The Chi-square test or Fisher's exact test will be employed to compare the percentage of participants may show a significant change in metabolic biomarker in the group that received Omega-3 versus the group that received a placebo. Pearson or Spearman correlation tests will be used to explore any relationships between baseline Omega-3 levels and baseline inflammatory marker (CRP) and lipid profile levels, as well as between the change in Omega-3 levels and the change in inflammatory marker (CRP) and lipid profile levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Rotterdam criteria for PCOS (Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS) 2004).
- •Age above 18 years up to 35 years
- •Newly diagnosed case of PCOS.
排除标准
- •Pregnancy and lactating mother.
- •History of diabetes mellitus (except those meeting metabolic syndrome criteria)
- •Any chronic illness (e.g. liver disease, kidney disease, cardiovascular disease)
- •Any acute or chronic infective or inflammatory disease.
- •Patients receiving Omega-3 supplementation within the last three months.
- •Exclusion of PCOS mimicking disease include hyperprolactinemia, adrenal hyperandrogenism, ovarian hyperandrogenism, cushing's syndrome, acromegaly etc.
- •Known allergy to fish oil or Omega-3 supplements.
研究组 & 干预措施
Omega-3
Participants received Omega-3 1gm tablet orally twice daily for 12 weeks.
干预措施: Omega 3 fatty acids (Drug)
Omega-3
Participants received Omega-3 1gm tablet orally twice daily for 12 weeks.
干预措施: Omega -3 fatty acids (Drug)
placebo
Participants received Omega-3 1gm placebo matching Omega-3 tablet orally twice daily for 12 weeks
干预措施: Omega 3 fatty acids (Drug)
placebo
Participants received Omega-3 1gm placebo matching Omega-3 tablet orally twice daily for 12 weeks
干预措施: Omega -3 fatty acids (Drug)
结局指标
主要结局
Effect of Omega-3 Supplementation as Add on Therapy on Metabolic Syndrome in Women with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial
时间窗: 12 weeks.
Changes in Lipid profile (Triglycerides, HDL-Cholesterol) Omega3 reduce Triglyceride and increase HDL Cholesterol Changes in CRP Plasma Omega-3 level (changes in plasma DHA and EPA conc. from baseline to 12 weeks) Changes in BMI,Omega3 reduce weight as well as BMI. Improvement of menstrual cycle regularity. Improvement of hirsutism.
次要结局
未报告次要终点
研究者
Dr. Fariba kabir
Principal investigator: Dr. Fariba Kabir, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka Bangladesh.
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh