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

NCT03778099 | Completed Phase 3

• 1 other identifier: W-001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Polycystic Ovary Syndrome; Ovulation

Keywords

PCOS; Ovulation; Cinnamon

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Pregnancy Rate

  3 months

Study Arms (2)

Cinnamon Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Cinnamon Cap 500 MG DRUG

The Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator.

Cinnamon Group

Placebo DRUG

450 mg of starch and 50 mg of cinnamon powder

Placebo Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women with PCOS
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, 21589, Saudi Arabia

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Wael H Alzhrani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 19, 2018
• Study Start: September 20, 2018
• Primary Completion: January 10, 2020
• Study Completion: February 3, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

SA (1)