Bioavailability of Single-dose Magnesium Salts

June 23, 2020 updated by: Think Healthy Group, Inc.

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 Overview

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18- 65 years
  2. Body mass index 18 to 35 kg/m2 , body weight ≥ 110 pounds or 50 kg
  3. All race/ethnicities and both sexes, are eligible.
  4. Normal blood pressure (BP) ≤ 120/80 mm Hg.

Exclusion Criteria:

  1. Participant has a diagnosis of hypertension, prehypertension, diabetes, cardiovascular or other chronic disease (e.g., cancer).
  2. Participant has a diagnosis of hypermagnesemia (defined as a serum concentration of > 22.8 mg/L of Magnesium) (4).
  3. 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.
  4. 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.
  5. Participant has gastrointestinal disease, hepatitis, anemia, or hepatic enzyme abnormalities.
  6. Women subjects are currently pregnant or trying to become pregnant.
  7. Participant has a history of hospitalization for acute illness in the previous 1 month.
  8. Participants who do not speak English or are unable to read or fail to comprehend the informed consent form.
  9. 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).
  10. Participants who have a body weight less than 110lbs (or 50kg).
  11. Participants who have donated blood within the last month, or are currently giving blood for other clinical or research purposes.
  12. Participants who smoke and/or use tobacco products.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo
Experimental: Picometer-ionic form of magnesium chloride
Single-dose (300 mg) of the picometer-ionic form of magnesium chloride
Active Comparator: Magnesium citrate or magnesium oxide
Single-dose (300 mg) of magnesium citrate or magnesium oxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
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.
24 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Taylor C. Wallace, PhD, Think Healthy Group, Inc.
  • Principal Investigator: Nana Gletsu-Miller, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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