Polycystic Ovary SyndromePhase 1/2FolicacidPCOSNCT03268733
The Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome
A Phase 1/2 study testing Folic Acid in people with Polycystic Ovary Syndrome, run by University of Khartoum at 1 site in Sudan.
Trial summary
An open clinical trial Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSudan
- Study dates
- 1 Sep 2017to 1 Sep 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sudan1 site, 1 recruiting
- Recruiting
Saad Abul ella fertility Centre
Khartoum, 11111
Mohammed ibrahim Awad, 00249900904060, awad22mohd@gmail.com
About this study
Official title: The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS)
An open clinical trial
Read the detailed description
The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number will receive no folic acid
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Folic Acid
- Keywords
- Folic acid, PCOS, Insulin resistance, Infertility
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDrug
Tablet 5 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 45 PCOS patients will receive 5 mg folic acid Receives: Drug: Folic Acid |
| control group | No intervention | 45 PCOS patients will receive no folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rates
Pregnancy rates will be compared in the treatment group and control group
Measured: 3 months
Ovulatory pattern improvements
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
Measured: 3 months
Clinical signs of hyperandrogenemia
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
Measured: 3 months
Secondary outcomes (4)
Plasma level of testosterone
Plasma level of testosterone will be compared in the treatment group and control group
Measured: 3 months
Plasma level of insulin
Plasma level of insulin will be compared in the treatment group and control group
Measured: 3 months
Plasma level of follicle-stimulating hormone (FSH)
Plasma level of follicle-stimulating hormone will be compared in the treatment group and control group
Measured: 3 months
Plasma level of luteinizing hormone (LH)
Plasma level of luteinizing hormone will be compared in the treatment group and control group
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open trial
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Collaborators
- Awad, Mohamed Ibrahim, M.D., Duria abdulwahab Elrrayes
- Responsible party
- Principal investigator, Mohammed Hassan Alnazeer, University of Khartoum
- Investigators
- Mohammed Hassan Alnazeer, Study chair, University of Khartoum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268733
- Sponsor's protocol ID
- Folic acid in PCOS
- Acronym
- FolicacidPCOS
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2017
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Biochemical Effects of Folic Acid on Sudanese Women With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT03268733
- Acronym / sponsor ID
- FolicacidPCOS / Folic acid in PCOS
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Folic acid, PCOS, Insulin resistance, Infertility
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Collaborators
- Awad, Mohamed Ibrahim, M.D., Duria abdulwahab Elrrayes
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open clinical trial
Detailed description
The patients with PCOS will be recruited to receive folic acid (45 patients) and equal number will receive no folic acid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Folic Acid45 PCOS patients will receive 5 mg folic acid |
| control group | No intervention | –45 PCOS patients will receive no folic acid |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic AcidTablet 5 mg | Drug | Treatment group |
Primary outcome
pregnancy rates
Time frame: 3 months
Pregnancy rates will be compared in the treatment group and control group
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
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
4 secondary outcomes
Plasma level of testosterone
Time frame: 3 months
Plasma level of insulin
Time frame: 3 months
Plasma level of follicle-stimulating hormone (FSH)
Time frame: 3 months
Plasma level of luteinizing hormone (LH)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Individual participant dataSharing planned: Undecided. still undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Hassan Alnazeer study chair
University of Khartoum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Folic Acid in people with Polycystic Ovary Syndrome, run by University of Khartoum at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Hassan Alnazeer (00249912907268, mhmd_nazir83@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rates (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.