Magnesium DeficiencyNCT06979648
Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels
A study testing Qualia Magnesium+® in people with Magnesium Deficiency, run by Qualia Life Sciences at 1 site in United States.
Trial summary
This is a double-blind, placebo-controlled parallel trial designed to evaluate the effectiveness of Qualia Magnesium+® supplementation on red blood cell (RBC) magnesium levels in adults aged 21 and older. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Magnesium Deficiency
- What is being tested?
- Qualia Magnesium+®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 29 Dec 2025
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide voluntary, written, informed consent to participate in the study
- Agree to provide a valid cell phone number and are willing to receive communications through text
- Can read and write English
- Willing to complete questionnaires, records, and diaries associated with the study.
- Male and female participants aged 21 years and older
- Willing and able to visit a local blood draw facility for required blood sample collections
Show all 10Show fewer
- Live within 20 miles of a suitable blood draw facility (such as Quest)
- RBC Magnesium levels below 6.0 mg/dL
- Willing to not consume any supplements containing magnesium starting about 2 weeks prior to the baseline magnesium blood test and continuing through the intervention period.
- Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly with the exception of those containing magnesium
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
- Known food intolerances/allergy to any ingredients in the product
- Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer
- Having had a significant cardiovascular event in the past 6 months
- Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
- On immunosuppressive therapy
- Individuals who were deemed incompatible with the test protocol
- Adults lacking capacity to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels: A Double-Blind Parallel Trial
This is a double-blind, placebo-controlled parallel trial designed to evaluate the effectiveness of Qualia Magnesium+® supplementation on red blood cell (RBC) magnesium levels in adults aged 21 and older. Approximately 100 participants with baseline RBC magnesium levels below 6.0 mg/dL will be assigned using systematic allocation to receive either Qualia Magnesium+ or a placebo. Participants will take 2 capsules daily in the evening, with or without food, for a duration of 12 weeks. The primary outcome is the between-group change in RBC magnesium levels from baseline to Week 12. Secondary outcomes include assessments of sleep quality, perceived stress, magnesium status, and safety and tolerability. Data collection will occur through lab bloodwork and electronic questionnaires.
Read the detailed description
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
- Conditions
- Magnesium Deficiency
- Being tested
- Qualia Magnesium+®, Placebo
- Keywords
- Magnesium supplementation, magnesium
- Medical subject headings
- Magnesium Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualia Magnesium+®Dietary supplement
Qualia Magnesium+® manufactured by Qualia Life Sciences
PlaceboDietary supplement
Rice Flour
| Study group | Role | What they receive |
|---|---|---|
| Qualia Magnesium+® | Active comparator | Qualia Magnesium+® Supplement Receives: Dietary Supplement: Qualia Magnesium+® |
| Placebo | Placebo comparator | Rice Flour Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group change in RBC magnesium levels
To assess the between-group change in RBC magnesium levels from baseline to Week 12 following supplementation with Qualia Magnesium+ or placebo.
Measured: 12 weeks
Secondary outcomes (6)
To evaluate changes in sleep quality using the PROMIS Sleep Disturbance Short Form
Measured: 4, 8, and 12 weeks
To assess perceived stress levels with the PSS-10
Measured: 4, 8, and 12 weeks
To evaluate changes in the magnesium status using the Magnesium Status Questionnaire
Measured: 4, 8, and 12 weeks
Side effect profile as measured by a custom Safety and Tolerability survey
Number of participants with treatment-related adverse events as assessed by a score of 3 or greater on the Safety and Tolerability survey
Measured: 4, 8, and 12 weeks
To assess changes in serum magnesium levels
Measured: 4, 8, and 12 weeks
Between-group change in RBC magnesium levels
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start14 Jul 2025
- Primary completion26 Dec 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnesium DeficiencyStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qualia Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979648
- Sponsor's protocol ID
- QLS-011
- Status last verified
- Oct 2026
- First submitted
- 13 May 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Qualia Magnesium+® Supplementation on RBC Magnesium Levels: A Double-Blind Parallel Trial
- ClinicalTrials.gov ID
- NCT06979648
- Acronym / sponsor ID
- QLS-011
- Conditions
- Magnesium Deficiency
- Keywords
- Magnesium supplementation, magnesium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Qualia Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 20 May 2025 (actual)
- 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, placebo-controlled parallel trial designed to evaluate the effectiveness of Qualia Magnesium+® supplementation on red blood cell (RBC) magnesium levels in adults aged 21 and older. Approximately 100 participants with baseline RBC magnesium levels below 6.0 mg/dL will be assigned using systematic allocation to receive either Qualia Magnesium+ or a placebo. Participants will take 2 capsules daily in the evening, with or without food, for a duration of 12 weeks. The primary outcome is the between-group change in RBC magnesium levels from baseline to Week 12. Secondary outcomes include assessments of sleep quality, perceived stress, magnesium status, and safety and tolerability. Data collection will occur through lab bloodwork and electronic questionnaires.
Detailed description
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qualia Magnesium+® | Active comparator | Dietary Supplement: Qualia Magnesium+®Qualia Magnesium+® Supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboRice Flour |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provide voluntary, written, informed consent to participate in the study
- Agree to provide a valid cell phone number and are willing to receive communications through text
- Can read and write English
- Willing to complete questionnaires, records, and diaries associated with the study.
- Male and female participants aged 21 years and older
Key exclusion criteria (8 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
- Known food intolerances/allergy to any ingredients in the product
- Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer
- Having had a significant cardiovascular event in the past 6 months
- Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
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 |
|---|---|---|
| Qualia Magnesium+®Qualia Magnesium+® manufactured by Qualia Life Sciences | Dietary supplement | Qualia Magnesium+® |
| PlaceboRice Flour | Dietary supplement | Placebo |
Primary outcome
Between-group change in RBC magnesium levels
Time frame: 12 weeks
To assess the between-group change in RBC magnesium levels from baseline to Week 12 following supplementation with Qualia Magnesium+ or placebo.
6 secondary outcomes
To evaluate changes in sleep quality using the PROMIS Sleep Disturbance Short Form
Time frame: 4, 8, and 12 weeks
To assess perceived stress levels with the PSS-10
Time frame: 4, 8, and 12 weeks
To evaluate changes in the magnesium status using the Magnesium Status Questionnaire
Time frame: 4, 8, and 12 weeks
Side effect profile as measured by a custom Safety and Tolerability survey
Time frame: 4, 8, and 12 weeks
To assess changes in serum magnesium levels
Time frame: 4, 8, and 12 weeks
Between-group change in RBC magnesium levels
Time frame: 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Magnesium Deficiency
Active, not recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
RecruitingObservational study
Magnesium in Gastrointestinal Disease
Colitis Ulcerosa, Colitis Ulcerative
RecruitingPhase 4
Magnesium Deficiency In Patients Hospitalized in Internal Medicine Wards
Hypomagnesemia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualia Magnesium+® in people with Magnesium Deficiency, run by Qualia Life Sciences at 1 site in United States.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 5 Oct 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group change in RBC magnesium levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.