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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Magnesium Citrate | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium 400Mg | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Quality from Baseline to 90 Days as Measured by PSQI Between Intervention and Control Groups | 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. |
| Change in Cognitive Function from Baseline to 90 Days as Measured by Trail Making Test (Parts A and B) Between Intervention and Control Group | 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. | From enrollment to the end of treatment at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure from Baseline to 90 Days Between Intervention and Control Groups | 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. | From enrollment to the end of treatment at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umm Al-Qura University | Mecca | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37045455 | Background | 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. | |
| 36635743 | Background | 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. |
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Individual participant data (IPD) will not be shared due to privacy and confidentiality considerations, as the dataset contains sensitive information that could potentially identify participants. Data will be presented in aggregate form to ensure participant anonymity.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 1, 2024 | Mar 31, 2026 |
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| Change in Serum Magnesium and HbA1C Levels from Baseline to 90 Days Between Intervention and Control Groups | 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. | From enrollment to the end of treatment at 90 days |
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| 35184264 | Background | 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. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| C110422 | magnesium citrate |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
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