- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07515417
Effect of Magnesium Supplementation on Sleep Quality and Cognitive Function in Saudi Adults
Effect of Magnesium Supplementation on Sleep Quality and Cognition in Saudi Adults: A Randomized Controlled Trial
The goal of this clinical trial was to evaluate whether magnesium citrate supplementation improved sleep quality and cognitive function in healthy Saudi adults. It also assessed the effects of magnesium on selected blood markers.
The main questions it aimed to answer were:
Did magnesium supplementation improve sleep quality? Did magnesium supplementation improve cognitive function?
Researchers compared participants who received magnesium citrate to a control group that did not receive any intervention to evaluate its effects.
Participants:
Took magnesium citrate (400 mg daily) for 90 days (two capsules: one in the afternoon and one 1-2 hours before bedtime)
Visited Umm Al-Qura University twice (before and after the intervention) for:
Sleep quality assessment Cognitive function assessment Blood sample collection to measure serum magnesium and HbA1c
The control group did not receive any supplementation during the study period.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants were instructed to take magnesium citrate supplements daily for 90 days and were provided with a diary to record their supplement intake and adherence throughout the study period. Any unconsumed capsules were left in the original bottle and returned during the follow-up visit to assess compliance. Participants were also asked to report any symptoms experienced during the intervention period. In addition, participants received reminders every two weeks via WhatsApp to encourage adherence to supplement intake.
Randomization codes were generated in advance using the RAND function in Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). Following confirmation of eligibility at the screening visit, participants were sequentially assigned to the next available intervention based on the pre-generated allocation list.
At baseline and after the intervention, participants completed a comprehensive assessment that included dietary intake using a Food Frequency Questionnaire (FFQ) and physical activity using the short form of the International Physical Activity Questionnaire (IPAQ). All questionnaires were administered in English. Anthropometric data, including weight and height, were self-reported by participants. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI), and cognitive function was assessed using the Trail Making Test Parts A and B. Blood pressure measurements were also recorded using standardized procedures.
Blood samples were collected at baseline (prior to the intervention, during the second visit) and again after 3 months (at the final visit). Participants were instructed to fast for 8 hours before both visits, with only water permitted, to standardize conditions and minimize the influence of dietary intake on serum magnesium levels.
Approximately 10 mL of blood was drawn via venipuncture by a qualified laboratory specialist using red or yellow-top tubes. The collected samples were processed and stored at -80°C for subsequent analysis of nutritional biomarkers, including serum magnesium and HbA1c.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mecca, Saudi Arabia
- Umm Al-Qura University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years and above
- Poor Sleep Quality (>5 PSQI score)
- Living in Saudi Arabia
Exclusion Criteria:
- Children less than 18 years old
- Good Sleep Quality (5 or less PSQI score)
- Pregnant or breastfeeding
- Current smoker
- History of sleep disorder
- History of cognitive impairment
- Diagnosed with a disease (e.g. diabetes, hypertension, celiac, psychiatric disease)
- Acute phase of diseases (e.g. cardiovascular)
- History of head injury (e.g. accident) or neurological disorders (e.g. seizures)/neurodevelopment disorders
- Use of prescribed medications within the past 3 months that may influence sleep
- Current use of hormone therapy (e.g. thyroxine, insulin, growth hormone, contraceptives)
- Use of dietary supplements within the previous 3 months (e.g. vitamin D, omega-3..etc)
- Food allergies/intolerances (e.g. eggs, nuts, milk)
- Excessive caffeine consumption (>450 mg/day, more than 4 cups)
- Shift worker or work schedules that cause irregular sleep patterns
- History of travel to a different time zone in the previous month
- Experiencing events that may cause severe stress for the previous 6 weeks from baseline (e.g. divorce or death or acute illness of a family member)
- Has children between 0-2 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
Eligible participants in the control group, identified as having poor sleep quality, did not receive any intervention during the study period.
All outcome measures, including sleep quality, cognitive function, anthropometric data, questionnaires, and blood samples, were collected at baseline and again after the 90-day study period.
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Experimental: Magnesium Citrate
Eligible participants received magnesium citrate (400 mg elemental magnesium/day) for 90 days, administered as two divided doses (afternoon and 1-2 hours before bedtime).
Compliance was monitored through participant diaries and returned capsule counts.
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Magnesium supplementation was administered to eligible participants using magnesium citrate tablets (Solgar®, USA), a highly bioavailable form commonly used in research. The supplements were purchased from Al Nahdi Pharmacy (Saudi Arabia) and selected based on previous studies demonstrating good absorption and effectiveness. Participants received a total daily dose of 400 mg elemental magnesium. Eligible participants were instructed to take the supplement for 90 days, divided into two doses: one in the afternoon and one 1-2 hours before bedtime. The supplement was provided in bottles containing 120 tablets. Participants were asked to maintain their usual diet and lifestyle. Compliance was monitored using participant diaries and by counting remaining capsules returned at the follow-up visit.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Sleep Quality from Baseline to 90 Days as Measured by PSQI Between Intervention and Control Groups
Time Frame: Participants were considered to have improved sleep quality if PSQI scores decreased from baseline to 90 days, especially if ≤5. Sleep outcomes were also compared between intervention and control groups after 90 days.
|
The Pittsburgh Sleep Quality Index (PSQI) is a widely used and validated instrument for assessing sleep quality in both clinical and healthy populations. Both the English and Arabic versions were used in this study, and both have been previously validated. It consisted of 19 items divided into seven sleep-related components: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each item was rated on a 4-point Likert scale based on frequency or severity. The component scores were summed to yield a global PSQI score ranging from 0 to 21. A score greater than five indicated poor sleep quality, while a score of five or less indicated good sleep quality. Participants were considered to have improved sleep quality if their PSQI scores decreased over time, particularly if their scores reached five or below |
Participants were considered to have improved sleep quality if PSQI scores decreased from baseline to 90 days, especially if ≤5. Sleep outcomes were also compared between intervention and control groups after 90 days.
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Change in Cognitive Function from Baseline to 90 Days as Measured by Trail Making Test (Parts A and B) Between Intervention and Control Group
Time Frame: From enrollment to the end of treatment at 90 days
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Cognitive function was assessed using the Trail Making Test (Parts A and B).
The test measured processing speed, attention, and executive function.
The primary outcome was the time (in seconds) required to complete each part, with longer times indicating poorer cognitive performance.
Changes in completion time from baseline to 90 days were evaluated and compared between intervention and control groups.
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From enrollment to the end of treatment at 90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Blood Pressure from Baseline to 90 Days Between Intervention and Control Groups
Time Frame: From enrollment to the end of treatment at 90 days
|
Blood pressure was measured using standardized procedures at baseline and after 90 days.
Both systolic and diastolic blood pressure (mmHg) were recorded.
Changes from baseline to 90 days were evaluated and compared between intervention and control groups.
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From enrollment to the end of treatment at 90 days
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Change in Serum Magnesium and HbA1C Levels from Baseline to 90 Days Between Intervention and Control Groups
Time Frame: From enrollment to the end of treatment at 90 days
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Blood samples were collected at baseline and after 90 days to measure serum magnesium and HbA1c levels.
Serum magnesium (mmol/L) and HbA1c (%) were analyzed using standard laboratory methods.
Changes from baseline to 90 days were evaluated and compared between intervention and control groups.
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From enrollment to the end of treatment at 90 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Suleiman KH, Yates BC, Berger AM, Pozehl B, Meza J. Translating the Pittsburgh Sleep Quality Index into Arabic. West J Nurs Res. 2010 Mar;32(2):250-68. doi: 10.1177/0193945909348230. Epub 2009 Nov 14.
- Ahmed AE, Al-Jahdali F, AlALwan A, Abuabat F, Bin Salih SA, Al-Harbi A, Baharoon S, Khan M, Ali YZ, Al-Jahdali H. Prevalence of sleep duration among Saudi adults. Saudi Med J. 2017 Mar;38(3):276-283. doi: 10.15537/smj.2017.3.17101.
- Shamim SA, Warriach ZI, Tariq MA, Rana KF, Malik BH. Insomnia: Risk Factor for Neurodegenerative Diseases. Cureus. 2019 Oct 26;11(10):e6004. doi: 10.7759/cureus.6004.
- Macian N, Duale C, Voute M, Leray V, Courrent M, Bode P, Giron F, Sonneville S, Bernard L, Joanny F, Menard K, Ducheix G, Pereira B, Pickering G. Short-Term Magnesium Therapy Alleviates Moderate Stress in Patients with Fibromyalgia: A Randomized Double-Blind Clinical Trial. Nutrients. 2022 May 17;14(10):2088. doi: 10.3390/nu14102088.
- Khan MA, Al-Jahdali H. The consequences of sleep deprivation on cognitive performance. Neurosciences (Riyadh). 2023 Apr;28(2):91-99. doi: 10.17712/nsj.2023.2.20220108.
- Baattaiah BA, Alharbi MD, Babteen NM, Al-Maqbool HM, Babgi FA, Albatati AA. The relationship between fatigue, sleep quality, resilience, and the risk of postpartum depression: an emphasis on maternal mental health. BMC Psychol. 2023 Jan 13;11(1):10. doi: 10.1186/s40359-023-01043-3.
- Zhang Y, Chen C, Lu L, Knutson KL, Carnethon MR, Fly AD, Luo J, Haas DM, Shikany JM, Kahe K. Association of magnesium intake with sleep duration and sleep quality: findings from the CARDIA study. Sleep. 2022 Apr 11;45(4):zsab276. doi: 10.1093/sleep/zsab276.
- Bamagoos AA, Altayeb AA, Rawas HF, Alsulaimani SS, Basurrah MA, Aleissi SA, Wali SO. Patterns of Sleep and Napping in Saudi Arabia: A Cross-sectional Evaluation. Saudi J Med Med Sci. 2025 Apr-Jun;13(2):124-132. doi: 10.4103/sjmms.sjmms_679_24. Epub 2025 Apr 21.
- Barbagallo M, Veronese N, Dominguez LJ. Magnesium in Aging, Health and Diseases. Nutrients. 2021 Jan 30;13(2):463. doi: 10.3390/nu13020463.
- Gallagher C, Austin V, Dunlop KA, Dally J, Taylor K, Pullinger SA, Edwards BJ. Effects of Supplementing Zinc Magnesium Aspartate on Sleep Quality and Submaximal Weightlifting Performance, following Two Consecutive Nights of Partial Sleep Deprivation. Nutrients. 2024 Jan 13;16(2):251. doi: 10.3390/nu16020251.
- Ajabnoor SM, Jambi H, Bahijri S. Development and validation of a food frequency questionnaire in adult Saudi subjects in Jeddah city. BMC Public Health. 2024 Jan 2;24(1):9. doi: 10.1186/s12889-023-17511-9.
- Gholizadeh-Moghaddam M, Ghasemi-Tehrani H, Askari G, Jaripur M, Clark CCT, Rouhani MH. Effect of magnesium supplementation in improving hyperandrogenism, hirsutism, and sleep quality in women with polycystic ovary syndrome: A randomized, placebo-controlled clinical trial. Health Sci Rep. 2022 Dec 29;6(1):e1013. doi: 10.1002/hsr2.1013. eCollection 2023 Jan.
- Grandner MA, Jackson NJ, Izci-Balserak B, Gallagher RA, Murray-Bachmann R, Williams NJ, Patel NP, Jean-Louis G. Social and Behavioral Determinants of Perceived Insufficient Sleep. Front Neurol. 2015 Jun 5;6:112. doi: 10.3389/fneur.2015.00112. eCollection 2015.
- Alqarni RA, Almutairi NS, Albalawi AS, Alsulami MB, Alhashrani MA, Bin Abdulrahman KA. Test-retest reliability of the Arabic version of the Pittsburgh Sleep Quality Index. Medicine (Baltimore). 2025 Jan 17;104(3):e41269. doi: 10.1097/MD.0000000000041269.
- Metwally A, Alalawi AD, Al Sarrar AA, Alamin OM, Saad AA, Almalki MD. Prevalence of Insomnia and Its Associated Factors in the General Population of Saudi Arabia: A Cross-Sectional Study. Cureus. 2023 Aug 29;15(8):e44342. doi: 10.7759/cureus.44342. eCollection 2023 Aug.
- Watanabe M, Maemura K, Kanbara K, Tamayama T, Hayasaki H. GABA and GABA receptors in the central nervous system and other organs. Int Rev Cytol. 2002;213:1-47. doi: 10.1016/s0074-7696(02)13011-7.
- Song Y, Chang Z, Song C, Cui K, Yuan S, Qiao Z, Bian X, Gao Y, Dou K. Association of sleep quality, its change and sleep duration with the risk of type 2 diabetes mellitus: Findings from the English longitudinal study of ageing. Diabetes Metab Res Rev. 2023 Sep;39(6):e3669. doi: 10.1002/dmrr.3669. Epub 2023 Jun 8.
- Qiu D, Yu Y, Li RQ, Li YL, Xiao SY. Prevalence of sleep disturbances in Chinese healthcare professionals: a systematic review and meta-analysis. Sleep Med. 2020 Mar;67:258-266. doi: 10.1016/j.sleep.2019.01.047. Epub 2019 Mar 6.
- Nielsen FH, Johnson LK, Zeng H. Magnesium supplementation improves indicators of low magnesium status and inflammatory stress in adults older than 51 years with poor quality sleep. Magnes Res. 2010 Dec;23(4):158-68. doi: 10.1684/mrh.2010.0220. Epub 2011 Jan 4.
- Keramat SA, Alam K, Basri R, Siddika F, Siddiqui ZH, Okyere J, Seidu AA, Ahinkorah BO. Sleep duration, sleep quality and the risk of being obese: Evidence from the Australian panel survey. Sleep Med. 2023 Sep;109:56-64. doi: 10.1016/j.sleep.2023.06.012. Epub 2023 Jun 24.
- Iranzo A. Sleep in Neurodegenerative Diseases. Sleep Med Clin. 2016 Mar;11(1):1-18. doi: 10.1016/j.jsmc.2015.10.011. Epub 2016 Jan 8.
- Chan V, Lo K. Efficacy of dietary supplements on improving sleep quality: a systematic review and meta-analysis. Postgrad Med J. 2022 Apr;98(1158):285-293. doi: 10.1136/postgradmedj-2020-139319. Epub 2021 Jan 13.
- Arab A, Rafie N, Amani R, Shirani F. The Role of Magnesium in Sleep Health: a Systematic Review of Available Literature. Biol Trace Elem Res. 2023 Jan;201(1):121-128. doi: 10.1007/s12011-022-03162-1. Epub 2022 Feb 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAPO-02-K-012-2025-01-2441
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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