Comparison of magnesium given by mouth to magnesium given through the vein to treat patients with low blood magnesium
| ISRCTN | ISRCTN16067597 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16067597 |
- Submission date
- 23/06/2022
- Registration date
- 25/08/2022
- Last edited
- 25/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Hypomagnesemia is when the amount of magnesium in the blood is too low. This can cause nausea and vomiting, sleepiness, muscle weakness, spasms, or tremors. This study will compare treatments for hypomagnesemia, comparing magnesium given by mouth to magnesium given through the vein in its ability to increase the blood magnesium level.
Who can participate?
Adult patients can participate if they are hospitalized and have a low magnesium level, are not taking certain medications (proton pump inhibitors, diuretic use), do not have kidney or intestinal problems, do not have severe infections, are not pregnant, and do not have heart problems happening at the same time.
What does the study involve?
Participants will be allocated to one of three groups, with an equal chance of being in each group (like tossing a coin). Participants in the first group will receive magnesium given by mouth, participants in the second group will receive magnesium given through injection into the vein at a normal rate, and participants in the third group will receive magnesium given through injection into the vein at a slow rate.
What are the possible benefits and risks of participating?
The possible benefits of participating to the individual include potential avoidance of another vein medication. The benefits to society include better understanding
Where is the study run from?
Riverside University Health Systems - Medical Center (USA)
When is the study starting and how long is it expected to run for?
June 2015 to September 2017
Who is funding the study?
Riverside University Health Systems - Medical Center (USA)
Who is the main contact?
Dr Alexander Friedman, alex.friedman@ruhealth.org
Contact information
Principal Investigator
26520 Cactus Ave
Moreno Valley
92555
United States of America
 ORCID ID |
0000-0001-5486-6852 |
|---|---|
| Phone | +1 9514864000 |
| alex.friedman@ruhealth.org |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 41970_PIS_Consent_English.pdf |
| Scientific title | Comparison of oral and intravenous magnesium repletion in patients with hypomagnesemia: a randomized controlled trial |
| Study objectives | Repletion with intravenous magnesium is non inferior to oral magnesium in raising serum magnesium level for mild to moderate hypomagnesemia |
| Ethics approval(s) | Approved 14/12/2015, Riverside University Health System Medical Center (RUHSMC) IRB (26520 Cactus Ave, Moreno Valley, CA 92555; +1 951 486 4098; IRB@RUhealth.org) |
| Health condition(s) or problem(s) studied | Hypomagnesemia |
| Intervention | Participants will be randomized into three groups. The randomization process will involve randomly generated numbers placed in sealed envelopes. Group 1 received magnesium oxide (MgOx) 400 mg tabs: 1600 mg, followed by 800 mg 4 h later. Group 2 received magnesium sulfate (MgSO4) 2 g IV infused over 2 . Group 3 was administered magnesium sulfate (MgSO4) 2 g IV, infused over 6 h. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | magnesium sulfate, magnesium oxide |
| Primary outcome measure | Absolute serum magnesium level measured from blood samples collected at the time of enrollment and between 18 and 30 h after initiation of repletion |
| Secondary outcome measures | The relative rise in serum magnesium level measured from blood samples collected at the time of enrollment and between 18 and 30 h after initiation of repletion |
| Overall study start date | 01/06/2015 |
| Completion date | 30/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 112 |
| Key inclusion criteria | 1. Inpatient at the participating medical center 2. Aged >18 years 3. Serum magnesium between 1.2 and 1.7 mg/dl |
| Key exclusion criteria | 1. Proton pump inhibitor (PPI) use 2. Concomitant diuretic use 3. Acute or chronic renal insufficiency 4. Active myocardial infarction 5. Eclampsia or preeclampsia 6. Pregnancy 7. Incarcerated status 8. Unable to tolerate oral intake 9. History of bowel surgery 10. Active diarrhea 11. Concomitant chemotherapy 12. Severe sepsis 13. Prior enrollment in the study |
| Date of first enrolment | 10/07/2015 |
| Date of final enrolment | 30/09/2017 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Moreno Valley
92555
United States of America
Sponsor information
Hospital/treatment centre
26520 Cactus Ave
Moreno Valley
92555
United States of America
| Phone | +1 9514864000 |
|---|---|
| alex.friedman@ruhealth.org | |
| Website | http://www.ruhealth.org/en-us |
"ROR" |
https://ror.org/020448x84 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer reviewed medical journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are/will be available upon request from Dr Alexander Friedman (alex.friedman@ruhealth.org). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Informed consent - English language | 25/08/2022 | No | Yes | |
| Participant information sheet | Informed consent - Spanish language | 25/08/2022 | No | Yes | |
| Protocol file | 25/08/2022 | No | No |
Additional files
- 41970_Protocol.pdf
- 41970_PIS_Consent_Spanish.pdf
- Informed consent - Spanish language
- 41970_PIS_Consent_English.pdf
- Informed consent - English language
Editorial Notes
25/08/2022: Trial’s existence confirmed by Riverside University Health System Medical Center (RUHSMC) IRB.
