100 Participants Needed

Qualia Magnesium+ for Magnesium Deficiency

WS
Overseen ByWilliam Scuba

Trial Summary

What is the purpose of this trial?

This is a randomized, 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 randomly assigned 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.

Eligibility Criteria

Adults over 21 with low red blood cell magnesium levels (below 6.0 mg/dL) can join this trial. It's not for those who have other health conditions that might interfere with the study or if they're taking certain medications affecting magnesium levels.

Inclusion Criteria

RBC Magnesium levels below 6.0 mg/dL
I can go to a clinic for blood tests.
Provide voluntary, written, informed consent to participate in the study
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Exclusion Criteria

Known food intolerances/allergy to any ingredients in the product
Individuals who were deemed incompatible with the test protocol
I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Qualia Magnesium+ or placebo for 12 weeks

12 weeks
Regular lab bloodwork and electronic questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Qualia Magnesium+®
Trial Overview The trial is testing Qualia Magnesium+® against a placebo to see if it raises RBC magnesium levels in participants. They'll take two capsules every evening for 12 weeks, and researchers will check their blood, sleep quality, stress, and overall safety of the supplement.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Qualia Magnesium+®Active Control1 Intervention
Qualia Magnesium+® Supplement
Group II: PlaceboPlacebo Group1 Intervention
Rice Flour

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Who Is Running the Clinical Trial?

Qualia Life Sciences

Lead Sponsor

Trials
2
Recruited
290+
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