Polycystic Ovary SyndromeNCT02178150
Effect of Magnesium Supplementation on Polycystic Ovary Syndrome
A study testing Magnesium Oxide in people with Polycystic Ovary Syndrome, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size calculated 70 persons (35 persons for control group and 35 persons for patient group). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Magnesium Oxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Having PCOS according to the Rotterdam criteria,
- Age between 20-45 years,
- Lack of pregnancy and lactation,
- Not having certain regime during last 3 months,
- Non-smoking,
- Not having diseases, including: diabetes, cardiovascular , hepatic, renal and thyroid,
- Not taking supplements,
- Being overweight (Kg / m 25 ≤ BMI)
Who cannot join
- Hormone Therapy,
- Pregnancy and lactation during the study,
- Severe weight loss (more than 2.5 kg per month) during the study
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Isfahan University of Medical Sciences
Isfahan, Isfahan
Ahmad Esmaeilzadeh, professor, 3117922776 ext. 0098, esmaillzadeh@hlth.mui.ac.ir
Ahmad Esmaeilzadeh, professor
About this study
Official title: Effect of Magnesium Supplementation on Metabolic Profile and Sex Hormone Levels in Overweight Women With Polycystic Ovary Syndrome.
This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size calculated 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including sex hormone levels, metabolic and inflammatory profiles will be measured at the beginning and end of the study as well as anthropetric measurements.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Magnesium Oxide, Placebo
- Keywords
- Magnesium, Insulin Resistance, Lipid profile, Sex hormones, Inflammatory factors
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium OxideDietary supplement
This is a double-blind randomized clinical trial which will be started at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size was calculated to be 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic and inflammatory profiles,sex hormone levels will be measured at the beginning and end of the study as well as anthropometric measurements.
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Oxide | Active comparator | magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet Receives: Dietary Supplement: Magnesium Oxide |
| Placebo | Placebo comparator | Placebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum insulin level
Measured: 8 Weeks
Secondary outcomes (12)
Insulin Resistance
Measured: 8 weeks
Fasting Blood Sugar
Measured: 8 weeks
Quantitative insulin sensitivity check index (Quicki)
Measured: 8 weeks
HOMA-IR
Measured: 8 weeks
HOMA-B
Measured: 8 weeks
High Density Lipoprotein
Measured: 8 weeks
Low Density Lipoprotein
Measured: 8 weeks
Triglyceride
Measured: 8 weeks
Total Cholesterol
Measured: 8 weeks
Androgen
Measured: 8 weeks
Testosterone
Measured: 8 weeks
C-Reactive Protein
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Azadbakht, Isfahan University of Medical Sciences
- Investigators
- Ahmad Esmaeilzadeh, professor, Study chair, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178150
- Sponsor's protocol ID
- 18201
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Farsinejad-Marj M, Azadbakht L, Mardanian F, Saneei P, Esmaillzadeh A. Clinical and Metabolic Responses to Magnesium Supplementation in Women with Polycystic Ovary Syndrome. Biol Trace Elem Res. 2020 Aug;196(2):349-358. doi: 10.1007/s12011-019-01923-z. Epub 2020 Jan 20.
PubMed 31960275
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Supplementation on Metabolic Profile and Sex Hormone Levels in Overweight Women With Polycystic Ovary Syndrome.
- ClinicalTrials.gov ID
- NCT02178150
- Acronym / sponsor ID
- 18201
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Magnesium, Insulin Resistance, Lipid profile, Sex hormones, Inflammatory factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Jun 2014 (estimated)
- 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.
This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size calculated 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including sex hormone levels, metabolic and inflammatory profiles will be measured at the beginning and end of the study as well as anthropetric measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Oxide | Active comparator | Dietary Supplement: Magnesium Oxidemagnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo tablets, the same in color, odor and appearance with magnesium tablets, 8 weeks, one tablet every day |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Having PCOS according to the Rotterdam criteria,
- Age between 20-45 years,
- Lack of pregnancy and lactation,
- Not having certain regime during last 3 months,
- Non-smoking,
Key exclusion criteria (3 listed)
- Hormone Therapy,
- Pregnancy and lactation during the study,
- Severe weight loss (more than 2.5 kg per month) during the study
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 |
|---|---|---|
| Magnesium OxideThis is a double-blind randomized clinical trial which will be started at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size was calculated to be 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic and inflammatory profiles,sex hormone levels will be measured at the beginning and end of the study as well as anthropometric measurements. | Dietary supplement | Magnesium Oxide |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Serum insulin level
Time frame: 8 Weeks
12 secondary outcomes
Insulin Resistance
Time frame: 8 weeks
Fasting Blood Sugar
Time frame: 8 weeks
Quantitative insulin sensitivity check index (Quicki)
Time frame: 8 weeks
HOMA-IR
Time frame: 8 weeks
HOMA-B
Time frame: 8 weeks
High Density Lipoprotein
Time frame: 8 weeks
Low Density Lipoprotein
Time frame: 8 weeks
Triglyceride
Time frame: 8 weeks
Total Cholesterol
Time frame: 8 weeks
Androgen
Time frame: 8 weeks
Testosterone
Time frame: 8 weeks
C-Reactive Protein
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Derived from this study: PubMed 31960275Farsinejad-Marj M, Azadbakht L, Mardanian F, Saneei P, Esmaillzadeh A. Clinical and Metabolic Responses to Magnesium Supplementation in Women with Polycystic Ovary Syndrome. Biol Trace Elem Res. 2020 Aug;196(2):349-358. doi: 10.1007/s12011-019-01923-z. Epub 2020 Jan 20.
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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.
Ahmad Esmaeilzadeh, professor study chair
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Oxide in people with Polycystic Ovary Syndrome, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 8 inclusion and 3 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 10 Mar 2015. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Ahmad Esmaeilzadeh, Professor (3117922776 ext. 0098, esmaillzadeh@hlth.mui.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum insulin level (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02178150, which also lists 1 linked publication.
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 10 Mar 2015.