NCT02178150

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 10, 2015

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

June 26, 2014

Last Update Submit

March 8, 2015

Conditions

Polycystic Ovary Syndrome

Keywords

MagnesiumInsulin ResistanceLipid profileSex hormonesInflammatory factors

Outcome Measures

Primary Outcomes (1)

  • Serum insulin level

    8 Weeks

Secondary Outcomes (12)

  • Insulin Resistance

    8 weeks

  • Fasting Blood Sugar

    8 weeks

  • Quantitative insulin sensitivity check index (Quicki)

    8 weeks

  • HOMA-IR

    8 weeks

  • HOMA-B

    8 weeks

  • +7 more secondary outcomes

Study Arms (2)

Magnesium Oxide

ACTIVE COMPARATOR

magnesium tablets, 250 milligram magnesium, 8 weeks, every day 1 tablet

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

Dietary Supplement: Placebo

Interventions

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.

Magnesium Oxide
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Hormone Therapy,
  • Pregnancy and lactation during the study,
  • Severe weight loss (more than 2.5 kg per month) during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Isfahan, Iran

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31960275DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Interventions

Magnesium Oxide

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Ahmad Esmaeilzadeh, professor

    Isfahan University of Medical Sciences

    STUDY CHAIR

Central Study Contacts

Ahmad Esmaeilzadeh, Professor

CONTACT

3117922776esmaillzadeh@hlth.mui.ac.ir

maryam farsinejadmarj, Bachelor

CONTACT

9374760794maryam.farsinejad@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 26, 2014

First Posted

June 30, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

March 10, 2015

Record last verified: 2014-06

Locations

IR(1)