BioavailabilityNCT04139928
Bioavailability of Single-dose Magnesium Salts
A study testing Picometer-ionic form of magnesium chloride and Magnesium citrate or magnesium oxide in people with Bioavailability, run by Think Healthy Group, Inc. at 1 site in United States.
Trial summary
Magnesium plays a role in an array of critical body functions, controls normal adenosine triphosphate function, the metabolism of glucose, and cardiac muscle function, as well as the maintenance of cell membrane function. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Picometer-ionic form of magnesium chloride and Magnesium citrate or magnesium oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 28 Apr 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18- 65 years
- Body mass index 18 to 35 kg/m2 , body weight ≥ 110 pounds or 50 kg
- All race/ethnicities and both sexes, are eligible.
- Normal blood pressure (BP) ≤ 120/80 mm Hg.
Who cannot join
- Participant has a diagnosis of hypertension, prehypertension, diabetes, cardiovascular or other chronic disease (e.g., cancer).
- Participant has a diagnosis of hypermagnesemia (defined as a serum concentration of > 22.8 mg/L of Magnesium) (4).
- Participant is already taking magnesium supplementation prior to the study or taking medications that interfere with magnesium metabolism, we are providing examples in an appendix.
- Participant has concurrent use of magnesium supplements and/or other nutrient supplements that interfere with magnesium absorption (e.g., calcium supplements) within 2-wk prior the first treatment or during the course of this study.
- Participant has gastrointestinal disease, hepatitis, anemia, or hepatic enzyme abnormalities.
- Women subjects are currently pregnant or trying to become pregnant.
Show all 12Show fewer
- Participant has a history of hospitalization for acute illness in the previous 1 month.
- Participants who do not speak English or are unable to read or fail to comprehend the informed consent form.
- Participants fail to complete the full medical questionnaire reviewed with them during the initial phone call (whether it be because they refuse to answer or because they don't know/understand the questions).
- Participants who have a body weight less than 110lbs (or 50kg).
- Participants who have donated blood within the last month, or are currently giving blood for other clinical or research purposes.
- Participants who smoke and/or use tobacco products.
Trial locations and contacts
1 site in 1 country.
About this study
Magnesium plays a role in an array of critical body functions, controls normal adenosine triphosphate function, the metabolism of glucose, and cardiac muscle function, as well as the maintenance of cell membrane function. Low magnesium intakes and blood levels have been associated with a number of chronic diseases including hypertension, type 2 diabetes, metabolic syndrome, vascular disease, osteoporosis, and colon cancer. Magnesium deficiency is common. In the U.S. population, nearly 4% of men and 7% of women have hypomagnesemia (typically defined as a serum concentration <0.75 mmol/L, or < 17mg/L), which has been previously shown to be associated with an increased risk of all-cause mortality after 30 years of follow-up. In addition, hypomagnesemia is seen in approximately 11% of hospitalized patients and 52% of patients in coronary care units. Approximately half of the U.S. population does not currently reach the estimated average requirement (EAR) for magnesium from food. Yet magnesium deficiency is often overlooked.
Magnesium is relatively well absorbed by the gut; oral bioavailability varies from 35 to 70% and depends on a variety of factors such as the form of the magnesium salt (organic vs. inorganic), its rate and extent of uptake from the intestine into the blood, and its transfer into tissues because magnesium is primarily an intracellular cation. The absorption rate increases when dietary intake is low. In terms of the effectiveness of oral dietary supplements, bioavailability and tolerability of various formulations are important considerations. Similar bioavailability has been demonstrated between inorganic formulations (magnesium oxide vs. magnesium chloride), however some studies have shown magnesium oxide to be less bioavailable. Diarrhea and abdominal cramping are side effects that are commonly reported from oral oral supplementation. These symptoms are thought to be due to the osmotic activity of unabsorbed salts in the intestine and colon and the stimulation of gastric motility. A new picometer-ionic form of magnesium chloride, was developed to efficiently deliver stabilized magnesium ions that are similar in size to plant magnesium. Picometer magnesium is smaller in diameter than the body's cell mineral ion channels, therefore it has the potential to be completely absorbed and not cause adverse side effects in the gastrointestinal system (e.g., diarrhea). The aim of this research is to assess the bioavailability of this new picometer-ionic form of magnesium chloride by comparing its bioavailability to that of a standard magnesium oxide and magnesium citrate supplement in healthy, adult, normotensive subjects.
- Conditions
- Bioavailability
- Being tested
- Picometer-ionic form of magnesium chloride, Magnesium citrate or magnesium oxide, Placebo
- Keywords
- Magnesium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picometer-ionic form of magnesium chlorideDietary supplement
Single-dose (300 mg) of the picometer-ionic form of magnesium chloride
Magnesium citrate or magnesium oxideDietary supplement
Single-dose (300 mg) of magnesium citrate or magnesium oxide
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Picometer-ionic form of magnesium chloride | Experimental | Not described Receives: Dietary Supplement: Picometer-ionic form of magnesium chloride |
| Magnesium citrate or magnesium oxide | Active comparator | Not described Receives: Dietary Supplement: Magnesium citrate or magnesium oxide |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ionized magnesium (whole blood)
Ionized magnesium in whole blood is the primary outcome measure which will be measured by using a magnesium selective electrode clinical analyzer (Stat Profile Prime® Model, Prime Electrolyte System) at multiple time points following the oral doses of the magnesium supplements (MgCl vs MgO vs placebo). The time points will be -15 minutes prior to dose and post dose at 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour and 24 hour.
Measured: 24 hours
Total magnesium in serum and urine
Total magnesium in serum and urine are the secondary outcome measures which will be measured by using inductively coupled plasma-mass spectrometry (ICP-MS) at multiple time points following the oral doses of the magnesium supplements (MgCl vs MgO vs placebo). The time points for serum total magnesium will be -15 minutes prior to dose and post dose at 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour and 24 hour. Complete urine collections will be obtained at pooled intervals that coincide with timing of blood draws.
Measured: 24 hours
Exploratory / Correlative Outcome Measures
A reference range for ionized magnesium in whole blood in healthy adults will be established for the magnesium selective electrode clinical analyzer.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Aug 2018
- Primary completion24 Mar 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BioavailabilityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Think Healthy Group, Inc.
- Sponsor type
- Research network
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Taylor C. Wallace, PhD, Principal investigator, Think Healthy Group, LLCNana Gletsu-Miller, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139928
- Sponsor's protocol ID
- THG-IU-MG-1
- Status last verified
- Apr 2024
- First submitted
- 23 Oct 2019
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ansu Baidoo VY, Thiagarajah K, Tekwe CD, Wallace TC, Gletsu-Miller N. Relationship between short-term self-reported dietary magnesium intake and whole blood ionized magnesium (iMg2+) or serum magnesium (s-Mg) concentrations. Ann Med. 2023 Dec;55(1):2195702. doi: 10.1080/07853890.2023.2195702.
PubMed 37036758Zhan J, Wallace TC, Butts SJ, Cao S, Ansu V, Spence LA, Weaver CM, Gletsu-Miller N. Circulating Ionized Magnesium as a Measure of Supplement Bioavailability: Results from a Pilot Study for Randomized Clinical Trial. Nutrients. 2020 Apr 28;12(5):1245. doi: 10.3390/nu12051245.
PubMed 32353962
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Single-dose Magnesium Salts
- ClinicalTrials.gov ID
- NCT04139928
- Acronym / sponsor ID
- THG-IU-MG-1
- Conditions
- Bioavailability
- Keywords
- Magnesium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Think Healthy Group, Inc.Research network
- Collaborators
- Indiana University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 25 Oct 2019 (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.
Magnesium plays a role in an array of critical body functions, controls normal adenosine triphosphate function, the metabolism of glucose, and cardiac muscle function, as well as the maintenance of cell membrane function. Low magnesium intakes and blood levels have been associated with a number of chronic diseases including hypertension, type 2 diabetes, metabolic syndrome, vascular disease, osteoporosis, and colon cancer. Magnesium deficiency is common. In the U.S. population, nearly 4% of men and 7% of women have hypomagnesemia (typically defined as a serum concentration <0.75 mmol/L, or < 17mg/L), which has been previously shown to be associated with an increased risk of all-cause mortality after 30 years of follow-up. In addition, hypomagnesemia is seen in approximately 11% of hospitalized patients and 52% of patients in coronary care units. Approximately half of the U.S. population does not currently reach the estimated average requirement (EAR) for magnesium from food. Yet magnesium deficiency is often overlooked.
Magnesium is relatively well absorbed by the gut; oral bioavailability varies from 35 to 70% and depends on a variety of factors such as the form of the magnesium salt (organic vs. inorganic), its rate and extent of uptake from the intestine into the blood, and its transfer into tissues because magnesium is primarily an intracellular cation. The absorption rate increases when dietary intake is low. In terms of the effectiveness of oral dietary supplements, bioavailability and tolerability of various formulations are important considerations. Similar bioavailability has been demonstrated between inorganic formulations (magnesium oxide vs. magnesium chloride), however some studies have shown magnesium oxide to be less bioavailable. Diarrhea and abdominal cramping are side effects that are commonly reported from oral oral supplementation. These symptoms are thought to be due to the osmotic activity of unabsorbed salts in the intestine and colon and the stimulation of gastric motility. A new picometer-ionic form of magnesium chloride, was developed to efficiently deliver stabilized magnesium ions that are similar in size to plant magnesium. Picometer magnesium is smaller in diameter than the body's cell mineral ion channels, therefore it has the potential to be completely absorbed and not cause adverse side effects in the gastrointestinal system (e.g., diarrhea). The aim of this research is to assess the bioavailability of this new picometer-ionic form of magnesium chloride by comparing its bioavailability to that of a standard magnesium oxide and magnesium citrate supplement in healthy, adult, normotensive subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Picometer-ionic form of magnesium chloride | Experimental | Dietary Supplement: Picometer-ionic form of magnesium chloride |
| Magnesium citrate or magnesium oxide | Active comparator | Dietary Supplement: Magnesium citrate or magnesium oxide |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18- 65 years
- Body mass index 18 to 35 kg/m2 , body weight ≥ 110 pounds or 50 kg
- All race/ethnicities and both sexes, are eligible.
- Normal blood pressure (BP) ≤ 120/80 mm Hg.
Key exclusion criteria (12 listed)
- Participant has a diagnosis of hypertension, prehypertension, diabetes, cardiovascular or other chronic disease (e.g., cancer).
- Participant has a diagnosis of hypermagnesemia (defined as a serum concentration of > 22.8 mg/L of Magnesium) (4).
- Participant is already taking magnesium supplementation prior to the study or taking medications that interfere with magnesium metabolism, we are providing examples in an appendix.
- Participant has concurrent use of magnesium supplements and/or other nutrient supplements that interfere with magnesium absorption (e.g., calcium supplements) within 2-wk prior the first treatment or during the course of this study.
- Participant has gastrointestinal disease, hepatitis, anemia, or hepatic enzyme abnormalities.
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 |
|---|---|---|
| Picometer-ionic form of magnesium chlorideSingle-dose (300 mg) of the picometer-ionic form of magnesium chloride | Dietary supplement | Picometer-ionic form of magnesium chloride |
| Magnesium citrate or magnesium oxideSingle-dose (300 mg) of magnesium citrate or magnesium oxide | Dietary supplement | Magnesium citrate or magnesium oxide |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Ionized magnesium (whole blood)
Time frame: 24 hours
Ionized magnesium in whole blood is the primary outcome measure which will be measured by using a magnesium selective electrode clinical analyzer (Stat Profile Prime® Model, Prime Electrolyte System) at multiple time points following the oral doses of the magnesium supplements (MgCl vs MgO vs placebo). The time points will be -15 minutes prior to dose and post dose at 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour and 24 hour.
Total magnesium in serum and urine
Time frame: 24 hours
Total magnesium in serum and urine are the secondary outcome measures which will be measured by using inductively coupled plasma-mass spectrometry (ICP-MS) at multiple time points following the oral doses of the magnesium supplements (MgCl vs MgO vs placebo). The time points for serum total magnesium will be -15 minutes prior to dose and post dose at 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour and 24 hour. Complete urine collections will be obtained at pooled intervals that coincide with timing of blood draws.
Exploratory / Correlative Outcome Measures
Time frame: 24 hours
A reference range for ionized magnesium in whole blood in healthy adults will be established for the magnesium selective electrode clinical analyzer.
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 23 Apr 2024.
- Background: PubMed 37036758Ansu Baidoo VY, Thiagarajah K, Tekwe CD, Wallace TC, Gletsu-Miller N. Relationship between short-term self-reported dietary magnesium intake and whole blood ionized magnesium (iMg2+) or serum magnesium (s-Mg) concentrations. Ann Med. 2023 Dec;55(1):2195702. doi: 10.1080/07853890.2023.2195702.
- Results publication: PubMed 32353962Zhan J, Wallace TC, Butts SJ, Cao S, Ansu V, Spence LA, Weaver CM, Gletsu-Miller N. Circulating Ionized Magnesium as a Measure of Supplement Bioavailability: Results from a Pilot Study for Randomized Clinical Trial. Nutrients. 2020 Apr 28;12(5):1245. doi: 10.3390/nu12051245.
- Individual participant dataSharing planned: No
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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.
Taylor C. Wallace, PhD principal investigator
Think Healthy Group, LLC
Nana Gletsu-Miller, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Picometer-ionic form of magnesium chloride and Magnesium citrate or magnesium oxide in people with Bioavailability, run by Think Healthy Group, Inc. 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 4 inclusion and 12 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 23 Apr 2024. 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?
Ionized magnesium (whole blood) (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139928, which also lists 2 linked publications.
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 23 Apr 2024.