Abstract
Background
Myo-inositol, a glial marker which plays a critical role in some brain regions, can supposedly affect sleep processes. The purpose of randomized controlled trial was to evaluate the impact of myo-inositol supplementation on sleep quality of pregnant women.
Methods
The study enrolled 60 women with low risk singleton pregnancies, with a gestational age of at least 14 weeks, in Iran. The participants were block randomized to receive myo-inositol supplementation powder containing 2000 mg of myo-inositol and 200 μg of folic acid or placebo (400 μg of folic acid) for 10 weeks from the gestational age of 14–24. Sleep quality was measured by the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was the change in sleep quality from the first trimester to the second trimester (24–28 weeks). The ANCOVA with adjusted covariate variables in the first trimester was conducted to estimate the sleep quality between the two groups.
Results
The results of ANCOVA boot strapped showed that the mean difference of the total sleep quality score between the two groups was −1.537; 95% CI: −3.050 to −0.024, p = .047) in the second trimester at immediately post-intervention. Also, there were significant differences between the two groups in terms of subjective sleep quality (MD: −0.427; 95% CI: −0.725 to −0.128, p = .006, sleep duration (MD: −0.670; 95% CI: −1.240 to −0.101; p = .022) and habitual sleep efficiency (MD: −0.561; 95% CI: −1.038 to −0.085, p = .022).
Conclusion
The research confirmed that myo-inositol supplementation can improve global sleep quality, subjective sleep quality, and sleep duration during pregnancy. Therefore, these findings applied to minimize the rate of poor sleep quality in pregnant women.
Acknowledgments
The authors gratefully thank you for cooperation of Iranian pregnant women to this research study. We also truly appreciate our colleagues [Roya Mirfallah] who assisted the better collecting the data and the provided support with Babol University of Medical Sciences.
Informed consent
Written informed consent was obtained from all subjects before the study.
Trial registration
This study was registered in Iranian Registry of Clinical Trials (IRCTID: IRCT20160208026446N3).
Ethical approval
Ethical approval for this study was obtained from Babol University of Medical Science (Ethic ID: IR. MUBABOL.HRI.REC. 1397. 032).
Guarantor
MAD.
Author contribution
MAD, SMA, and FB contributed to design of the study. SMA and SE contributed for data collection. MAD contributed to the statistics analyses and interpreting data, writing manuscript as well provided study material and is the corresponding author. FB, MF and SE contributed to writing the manuscript. All authors read and approved the final manuscript.
Disclosure statement
No potential conflict of interest was reported by the author(s).