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The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (FolicacidPCOS)

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ClinicalTrials.gov Identifier: NCT03268733
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Collaborators:
Awad, Mohamed Ibrahim, M.D.
Duria abdulwahab Elrrayes
Information provided by (Responsible Party):
Mohammed Hassan Alnazeer, University of Khartoum

Brief Summary:
An open clinical trial

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Folic Acid Phase 1 Phase 2

Detailed Description:
The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number will receive no folic acid

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS)
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment group
45 PCOS patients will receive 5 mg folic acid
Drug: Folic Acid
Tablet 5 mg
No Intervention: control group
45 PCOS patients will receive no folic acid



Primary Outcome Measures :
  1. pregnancy rates [ Time Frame: 3 months ]
    Pregnancy rates will be compared in the treatment group and control group

  2. Ovulatory pattern improvements [ Time Frame: 3 months ]
    Ovulatory pattern will be assessed based on the history of the PCOS patients, the patients whom were having baseline oligomenorrhea or amenorrhea will be re-assessed for resuming regular cycles defined as periods lasting 22 - 35 days. this pattern improvement will be compared in the treatment group and control group using questionnaire

  3. Clinical signs of hyperandrogenemia [ Time Frame: 3 months ]
    Hirsutism will be used as a sign of hyperandrogenemia, Patients will be provided with modified Ferriman -Gallwey (mFG) images to self-rate hair growth in each of the 9 body areas (upper lip, chin, chest, upper and lower back, upper and lower abdomen, thighs, and upper arms). For each site, a score on a scale of 0 to 4 was recorded. A total score of 8 or greater is defined as clinical evidence of hirsutism; scores from 8 to 15 are considered mild hirsutism; scores from16 to 25 are considered moderate; and scores from 26 to 36 are considered severe hirsutism. The baseline and after 3 months hirsutism compared in the treatment group and control group


Secondary Outcome Measures :
  1. Plasma level of testosterone [ Time Frame: 3 months ]
    Plasma level of testosterone will be compared in the treatment group and control group

  2. Plasma level of insulin [ Time Frame: 3 months ]
    Plasma level of insulin will be compared in the treatment group and control group

  3. Plasma level of follicle-stimulating hormone (FSH) [ Time Frame: 3 months ]
    Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group

  4. Plasma level of luteinizing hormone (LH) [ Time Frame: 3 months ]
    Plasma level of luteinizing hormone will be compared in the treatment group and control group


Other Outcome Measures:
  1. Lipid profile [ Time Frame: 3 months ]
    Lipid profile will be compared in the treatment group and control group

  2. Plasma level of random glucose [ Time Frame: 3 months ]
    Plasma level of random glucose will be compared in the treatment group and control group

  3. Plasma level of folate [ Time Frame: 3 months ]
    Plasma level of folate will be compared in the treatment group and control group

  4. Plasma level of homocysteine (Hcy) [ Time Frame: 3 months ]
    Plasma level of homocysteine (Hcy) will be compared in the treatment group and control group

  5. Plasma level of hemoglobin (Hb) [ Time Frame: 3 months ]
    Plasma level of hemoglobin (Hb) will be compared in the treatment group and control group

  6. Plasma level of C-reactive protein (CRP) [ Time Frame: 3 months ]
    Plasma level of C-reactive protein (CRP) will be compared in the treatment group and control group



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female patients suffering from PCOS-related subfertility
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who will visit this centre suffering from PCOS-related subfertility will be invited to be enrolled to this study if met the Rotterdam criteria for the diagnosis of PCOS

Exclusion Criteria:

  • The patients whom will be excluded from the study are those comorbid with hyperprolactinemia, congenital adrenal hyperplasia, diabetes mellitus, significant cardiovascular problems, thyroid dysfunctions, unresolved medical conditions, or using medications suspected to affect reproductive or metabolic functions within two months of the study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268733


Contacts
Contact: Mohammed Hassan Alnazeer 00249912907268 mhmd_nazir83@yahoo.com

Locations
Sudan
Saad Abul ella fertility Centre Recruiting
Khartoum, Sudan, 11111
Contact: Mohammed ibrahim Awad    00249900904060    awad22mohd@gmail.com   
Sponsors and Collaborators
University of Khartoum
Awad, Mohamed Ibrahim, M.D.
Duria abdulwahab Elrrayes
Investigators
Study Chair: Mohammed Hassan Alnazeer University of Khartoum

Responsible Party: Mohammed Hassan Alnazeer, Clinical Pharmacist, University of Khartoum
ClinicalTrials.gov Identifier: NCT03268733     History of Changes
Other Study ID Numbers: Folic acid in PCOS
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: still undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohammed Hassan Alnazeer, University of Khartoum:
Folic acid
PCOS
Insulin resistance
Infertility

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs