NCT04139928

Bioavailability of Single-dose Magnesium Salts

Completed NA Last updated 23 April 2024

What this trial tests

NA trial testing Picometer-ionic form of magnesium chloride in Bioavailability in 17 participants. Completed in 28 April 2020.

Timeline

1 August 2018

Primary endpoint
24 March 2020

28 April 2020

Quick facts

Lead sponsor	Think Healthy Group, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	prevention
Enrollment	17
Start date	1 August 2018
Primary completion	24 March 2020
Estimated completion	28 April 2020
Sites	1 location across United States

Drugs / interventions tested

• Picometer-ionic form of magnesium chloride
• Magnesium citrate or magnesium oxide
• Placebo

Conditions studied

• Bioavailability — all drugs for Bioavailability →

Sponsor

Think Healthy Group, Inc.

Who can join

Adults 18 to 65, any sex, with Bioavailability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Circulating Ionized Magnesium as a Measure of Supplement Bioavailability: Results from a Pilot Study for Randomized Clinical Trial.
   Zhan J, Wallace TC, Butts SJ, Cao S, et al · · 2020 · cited 12× · PMID 32353962 · DOI 10.3390/nu12051245
2. Relationship between short-term self-reported dietary magnesium intake and whole blood ionized magnesium (iMg²⁺) or serum magnesium (s-Mg) concentrations.
   Ansu Baidoo VY, Thiagarajah K, Tekwe CD, Wallace TC, et al · · 2023 · cited 5× · PMID 37036758 · DOI 10.1080/07853890.2023.2195702