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Calcium and Magnesium Supplement

Effervescent Calcium-Magnesium Citrate for End-Stage Renal Disease

Phase 2 & 3
Recruiting
Led By Henry Quinones, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult subjects (> 21 years of age, any cause of CKD) of either gender of any ethnicity with CKD Stage V on hemodialysis will be recruited
Treatment with drugs for management of osteoporosis (bisphosphonate, teriparatide, or denosumab) or for chronic kidney disease, customary drugs for hypertension or diabetes, and exogenous estrogen or selective estrogen receptor modulators will be allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will explore whether effervescent calcium magnesium citrate (EffCaMgCit) can help people with end stage renal disease on hemodialysis by reducing the formation of calciprotein particles (CPP), which can cause heart and artery problems.

Who is the study for?
This trial is for adults over 21 with Chronic Kidney Disease Stage V on hemodialysis. It includes those with Type II diabetes and hypertension, and allows treatments for osteoporosis, kidney disease, hypertension or diabetes, and hormone therapies. Excluded are patients on steroids or aluminum antacids, with high serum magnesium levels or certain bowel diseases.Check my eligibility
What is being tested?
The study tests effervescent calcium magnesium citrate (EffCaMgCit) against CaAcS in reducing cardiovascular risks in CKD Stage V patients by slowing calcification and cardiac issues. It also examines EffCaMgCit's effects on serum FGF23 levels, alkali load, bone turnover, and bone mineral density.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects may include imbalances in electrolytes like calcium or magnesium leading to muscle weakness or arrhythmias; gastrointestinal symptoms such as bloating; and changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 21, on hemodialysis, and have stage V chronic kidney disease.
Select...
I am taking medication for osteoporosis, chronic kidney disease, high blood pressure, diabetes, or hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serum T50 for CPP
Secondary outcome measures
Control of hyperphosphatemia and serum FGF23
Intracellular muscle magnesium
Parathyroid function and bone turnover

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EffCaMgCitExperimental Treatment1 Intervention
Patients in the EffCaMgCit group will receive 45 meq (900 mg) Ca, 30 meq (365 mg) Mg, and 135 meq total citrate per day from 3 months to 2 years.
Group II: CaAcSActive Control1 Intervention
Patients in the CaAcS group will take 45 meq (900 mg) Ca and 45 meq acetate (without Mg or citrate) per day.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,043 Previous Clinical Trials
1,053,305 Total Patients Enrolled
Henry Quinones, MDPrincipal InvestigatorUTSW

Media Library

Effervescent Calcium-Magnesium Citrate (Calcium and Magnesium Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03565913 — Phase 2 & 3
Chronic Kidney Disease Research Study Groups: EffCaMgCit, CaAcS
Chronic Kidney Disease Clinical Trial 2023: Effervescent Calcium-Magnesium Citrate Highlights & Side Effects. Trial Name: NCT03565913 — Phase 2 & 3
Effervescent Calcium-Magnesium Citrate (Calcium and Magnesium Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03565913 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to enroll in this research project?

"Yes, this study is still looking for participants and was most recently updated on February 9th, 2022. The original posting date was January 22nd, 2017."

Answered by AI

Does this research only include young adults in their twenties?

"To be eligible for this particular trial, patients must be between 18-99 years old. However, there are other ongoing trials for patients that are under 18 and ones for patients that are over 65."

Answered by AI

How many research subjects are involved in this trial?

"Yes, the trial is still recruiting patients according to the information on clinicaltrials.gov. This specific study was first posted on 1/22/2017 and was edited on 2/9/2022. The research team is looking for 225 individuals total from 1 site."

Answered by AI

What are the requirements to sign up for this clinical trial?

"This study is currently enrolling 225 patients with chronic kidney disease. To be eligible, patients must be between 18 and 99 years old. In addition, the following criteria must be met: Adult subjects (> 21 years of age, any cause of CKD) of either gender of any ethnicity with CKD Stage V on hemodialysis will be recruited. Patients with Type II diabetes and hypertension will be allowed. Treatment with drugs for management of osteoporosis (bisphosphonate, teriparatide, or denosumab) or for chronic kidney disease, customary drugs for hypertension or diabetes, and exogenous estrogen or"

Answered by AI
~23 spots leftby Dec 2024