Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT04139928
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04139928
Study Brief:
Protocol Section:
NCT04139928