The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome (PCOS)

The Effect of Cinnamon on Ovulation Induction in Women With Polycystic Ovary Syndrome, Jeddah 2019: Randomized Double-blind Placebo-controlled Trial

Title: The effect of cinnamon supplementation on ovulation induction in women with polycystic ovary syndrome, Jeddah 2019: Randomized Double-Blind Placebo-controlled trial

Phase: III

Population: 118 women with polycystic ovary syndrome will be recruited from Obstetrics and Gynecology clinics in King Abdul-Aziz University Hospital, Jeddah 2019.

Subject Participation Duration: Each participant will be followed for three months.

Intervention: 2g of cinnamon capsules daily will be provided.

Objectives:

Primary Objective:

1. To compare the effectiveness of cinnamon supplement in combination with clomiphene citrate versus clomiphene citrate alone on ovulation in women with PCOS, in King Abdul-Aziz University Hospital in Jeddah 2019.
2. To measure the difference in insulin resistance after three months of cinnamon supplementation in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.
3. To determine the effect of cinnamon and CC on menstrual cyclicity, approximated by menstrual frequency, during the study period, in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019
4. To evaluate the quality of life in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019.

Secondary Objectives:

• To measure the pregnancy rate in women with PCOS in King Abdul-Aziz University Hospital, Jeddah 2019

Description of Study Design:

The participants will be randomized in 1:1 fashion. Allocation concealment will be ensured using similar bottles labeled by letters A and B, to receive either the combination of cinnamon supplement and clomiphene citrate or clomiphene citrate with placebo.

First visit: Patients will be evaluated during the early follicular phase for progesterone level and HOMA-IR and QUICK-I. Follow up: 3 months.

Last Visit: Patients will be re-evaluated to compare the difference.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Ovulation
• Intervention / Treatment: Drug: Cinnamon Cap 500 MG; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia, 21589
    • King Abdulaziz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Married women aged 18-40 seeking to become pregnant, meeting the Rotterdam criteria for polycystic ovary syndrome

Exclusion Criteria:

• Current pregnancy or lactation.
• Current use of treatment of infertility.
• Established diagnosis of diabetes mellitus.
• Use of Insulin-sensitizing treatment within the past three months.
• Hormonal treatment involving estrogen or progesterone within the past three months.
• Known hypersensitivity to cinnamon.
• Use of statin medication.
• Any other supplements that contain cinnamon within the past month.
• BMI <18.5 or BMI >35.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cinnamon Group; Two capsules of cinnamon 500mg twice per day after meals (2g/day). All capsules will be given simultaneously with the clomiphene citrate medication (standard treatment for infertility in women with PCOS). Participants will be asked to keep their normal lifestyle including daily food and physical activity level.	Drug: Cinnamon Cap 500 MG; The Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator.
Placebo Comparator: Placebo Group; Placebo capsules will contain 450 mg of starch and 50 mg of cinnamon powder (to improve blindness regarding taste and odor). Color, shape, and size of placebo capsules will be exactly the same as the cinnamon capsules. 2g/day along with clomiphene citrate	Drug: Placebo; 450 mg of starch and 50 mg of cinnamon powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ovulation Confirmation by Progesterone level	Progesterone level > 3ng/mL or pregnancy confirmed	3 months
Changes in insulin resistance	HOMA-IR	3 months
Menstrual frequency	No. of menses/ No. of months	3 months
Quality of life: Infertility quality of life questionnaire	The 36 FertiQoL items are rated according to 5 types of response scales. The response scales are: Very poor (0), poor (1), neither poor nor good (2), very good (4) Very dissatisfied (0), dissatisfied (1), neither satisfied nor dissatisfied (2), satisfied (3), very satisfied (4) Always (0), very often (1), quite often (2), Seldom (3), never (4) An extreme amount (0), very much (1), a moderate amount (2), a little (3), not at all (4) Completely (0), a great deal (1), moderately (2), not much (3), not at all (4) Scores on the response scales are reversed, summed and scaled to range from 0 to 100. Higher scores on the subscales and total scores indicate better quality of life.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy Rate	Number of pregnancies including live births, induced abortions, and fetal deaths / Number of women aged 18 - 40 years) × 1,000	3 months

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Wael H Alzhrani

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): February 3, 2020

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: PCOS; Cinnamon; Ovulation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: W-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No