EffCaMgCit for Low Magnesium and Osteoporosis Prevention
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByKhashayar Sakhaee, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Texas Southwestern Medical Center
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?Proton pump inhibitors (PPIs) are widely used for the control of gastric ulcer-gastritis, erosive esophagitis (gastroesophageal reflux disease), peptic ulcer disease (duodenal ulcer), and heartburn. Despite their efficacy, their use has been implicated in possibly causing fragility fractures (osteoporosis), hypomagnesemia (magnesium deficiency) and increased risk of chronic kidney disease (CKD). The current trial represents the investigators ongoing effort to discern whether these complications could be averted by effervescent calcium magnesium citrate (EffCaMgCit).
What data supports the effectiveness of the treatment EffCaMgCit for preventing osteoporosis?
Research suggests that magnesium supplementation can promote bone formation and prevent bone loss, which may help in osteoporosis prevention. Additionally, higher calcium intake is associated with a reduced risk of osteoporotic fractures, especially when the calcium to magnesium intake ratio is balanced.
345611Will I have to stop taking my current medications?
The trial requires that you continue taking your proton pump inhibitor (PPI) at a similar dosage. However, if you are taking certain other medications like adrenocorticosteroids, diuretics, or regular magnesium supplements, you may need to stop. Other medications will be considered individually.
How does the treatment EffCaMgCit differ from other osteoporosis treatments?
EffCaMgCit is unique because it combines calcium and magnesium in an effervescent form, which may enhance absorption compared to other calcium supplements. This combination could potentially improve bone health by addressing both calcium and magnesium deficiencies, which are important for bone metabolism.
137911Is EffCaMgCit safe for human use?
Research on similar calcium and magnesium supplements shows they are generally safe for human use, with studies indicating they can be absorbed well and support bone health. However, specific safety data for EffCaMgCit in humans is not directly available from the provided studies.
234810Eligibility Criteria
This trial is for adults over 21 who have been using proton pump inhibitors (like omeprazole) regularly and are expected to continue. They should have stage 1 hypertension, controlled type II diabetes with HbA1C under 7%, and no severe kidney issues or other conditions that require certain medications like steroids or bisphosphonates.Inclusion Criteria
I have been taking a strong acid reducer regularly for at least 2 months and will continue.
My Type II diabetes is under control with an HbA1C below 7%.
Exclusion Criteria
I am on dialysis for end-stage kidney failure.
My blood pressure is very high.
My diabetes type 2 is not well-controlled (HbA1C is 7% or higher).
Participant Groups
The study tests if effervescent calcium magnesium citrate can prevent bone weakening, magnesium deficiency, and kidney problems caused by long-term use of proton pump inhibitors. Participants will either receive this supplement (EffCaMgCit) or a placebo without knowing which one they're taking.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EffCaMgCitExperimental Treatment1 Intervention
38 meq (760 mg) Ca, 20 meq (243 mg) Mg, and 100 meq total citrate per day; designed to be added to 6 oz water for 1-2 minutes, to be dissolved/suspended before swallowing.
Group II: PlaceboPlacebo Group1 Intervention
Each sachet of Placebo will contain microcrystalline cellulose, but no calcium, magnesium or citrate. Placebo will be added to 6 oz water for 1-2 minutes, to be dissolved/suspended before swallowing.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Texas Southwestern Medical CenterDallas, TX
UT Southwestern Medical CenterDallas, TX
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
References
Trabecular bone density in a two year controlled trial of peroral magnesium in osteoporosis. [2016]Since magnesium regulates calcium transport, and magnesium replacement in magnesium-deficient postmenopausal patients resulted in unexpected improvement in documented osteoporosis, we investigated the effect of magnesium treatment on trabecular bone density in postmenopausal osteoporosis. Thirty-one postmenopausal patients (mean age +/- SD = 57.6 +/- 10.6 years), consecutively admitted to the Back Rehabilitation Unit with musculoskeletal pain of non-malignant origin and bone density values of 0.05). The mean bone density of the responders increased significantly both after one year (P
Acute biochemical variations induced by two different calcium salts in healthy perimenopausal women. [2019]Despite the potential utility of calcium supplementation and the availability of many calcium supplements in the market, there are few data concerning the absorbability of different calcium salts in different conditions. We have compared the acute metabolic responses following oral administration of calcium citrate (CC) or calcium gluconolactate and carbonate (CGC) given to 20 healthy perimenopausal women (aged 48-55 years). Ten women received two effervescent tablets of CC (each containing 500 mg of calcium) and 10 women received two effervescent tablets of CGC (each containing 500 mg of calcium). Before and on an hourly basis for 6 hours, serum total and ionized calcium, phosphate, and immunoreactive parathyroid hormone (iPTH) were measured. Urinary calcium and creatinine were also measured. Both calcium salts induced significant increase in serum total and ionized calcium and in urinary calcium excretion; they also significantly reduced circulating levels of iPTH. The analysis of ionized calcium and iPTH response curves to CC and CGC administration revealed a significantly greater bioavailability of CC compared with CGC. Our data suggest that CC could be prefered to CGC for its characteristics of absorbability and bioavailability.
Comparative study of the intestinal absorption of three salts of calcium in young and elderly women. [2018]A daily ingestion of 1000 to 1500 mg elemental calcium associated with vitamin D supplement is presently considered to be the adequate and least expensive therapy for senile osteoporosis. There exists only scarce data about calcium absorption with available calcium salts in elderly patients. We have compared the digestive absorption of calcium (Ca) citrate in soluble and solid form and calcium gluconolactate-carbonate in 15 young and 20 elderly, healthy women using the oral calcium loading test. The subjects were divided into two groups. In the first group, the absorption of solid Ca citrate (1000 mg Ca element) was compared to the absorption of Ca gluconolactate-carbonate (1000 mg Ca element) both in young (n = 7) and elderly women (n = 10). In the second group, the absorption of soluble Ca citrate (1000 mg Ca element) was compared to the absorption of Ca gluconolactate-carbonate (1000 mg Ca element) in young (n = 8) and elderly (n = 10) women. In the preload phase, basal calciuria was increased in elderly women (p
Dietary magnesium supplementation affects bone metabolism and dynamic strength of bone in ovariectomized rats. [2018]We evaluated the effect of magnesium supplementation on apparent calcium absorption, bone metabolism and dynamic bone strength in ovariectomized (OVX) rats as a model of postmenopausal women. Two groups of OVX rats were fed a 0.05% Mg diet or a 0.15% Mg diet, and one group of sham-operated rats was fed the 0.05% Mg diet for 42 d. We collected feces and urine of all rats for 3-d periods starting from d 3, 10, 17, 24, 31 and 38 of the feeding experiment for calcium and magnesium balance studies. Urine was collected for 24 h from d 41 of the feeding experiment for measuring deoxypyridinoline. After the 42 d, the rats were killed, serum prepared and femora excised. The apparent calcium absorption in the OVX rats fed 0.15% Mg was significantly lower than both other groups. Additionally, the urinary excretion of deoxypyridinoline (a bone resorption marker) and the serum parathyroid hormone level of the OVX rats fed the 0.15% Mg diet were significantly lower than in the OVX rats fed 0.05% Mg. Serum osteocalcin (a bone formation marker) in the OVX rats fed the 0.15% Mg diet was significantly higher than in the OVX rats fed 0.05% Mg. The breaking force and breaking energy of the femur in the OVX rats fed the 0.15% Mg diet were significantly higher than in the OVX rats fed the 0.05% Mg diet. These results indicate that magnesium supplementation reduces apparent calcium absorption, but promotes bone formation and prevents bone resorption in OVX rats. Moreover, our results indicate magnesium supplementation increases the dynamic strength of bone.
Effect of magnesium supplementation on the fractional intestinal absorption of 45CaCl2 in women with a low erythrocyte magnesium concentration. [2015]The cosupplementation of magnesium with calcium has been suggested to be beneficial in the prevention of osteoporosis. We investigated the effect of magnesium supplementation on parameters of bone resorption and fractional 45Ca absorption. Twenty apparently healthy women with a mean age of 39.2 +/- 9.2 years and an erythrocyte magnesium concentration less than 1.97 mmol/L were recruited into a controlled magnesium supplementation trial. During weeks 1 to 4, they received a daily control preparation, potassium/sodium citrate malate (PSCM). During weeks 5 to 8, the subjects received magnesium citrate malate (MCM) equivalent to 250 mg magnesium per day. During the fourth and eighth weeks, blood was collected for measurement of the serum intact parathyroid hormone (PTH) concentration and serum and erythrocyte magnesium concentration. Urine was collected for measurement of calcium, magnesium, creatinine, and deoxypyridinoline excretion. On the final day of each treatment period, 5 microCi45CaCl2 was administered orally, and the isotope was traced in the blood and urine over 7 hours. Urinary calcium, 45Ca, and deoxypyridinoline excretion, as well as serum intact PTH levels, showed no statistically significant changes as a result of magnesium supplementation. However, urinary magnesium excretion increased by 31.1% (P
Magnesium intake from food and supplements is associated with bone mineral density in healthy older white subjects. [2013]To determine whether magnesium intake from supplemental and dietary sources is associated with bone mineral density (BMD) in older men and women.
Short-term oral magnesium supplementation suppresses bone turnover in postmenopausal osteoporotic women. [2015]Magnesium has been shown to increase bone mineral density when used in the treatment of osteoporosis, yet its mechanism of action is obscure. In this study, the effects of daily oral magnesium supplementation on biochemical markers of bone turnover were investigated. Twenty postmenopausal women have been divided into two groups. Ten patients were given magnesium citrate (1,830 mg/day) orally for 30 days. Ten postmenopausal women of matching age, menopause duration, and BMI were recruited as the control group and followed without any medication. Fasting blood and first-void urine samples were collected on days 0, 1, 5, 10, 20, and 30, respectively. Total magnesium, calcium, phosphorus, iPTH and osteocalcin were determined in blood samples. Deoxypyridinoline levels adjusted for creatinine were measured in urine samples. Thirty consecutive days of oral magnesium supplementation caused significantly decrease in serum iPTH levels in the Mg-supplemented group (p
The effects of Mg supplementation in diets with different calcium levels on the bone status and bone metabolism in growing female rats. [2013]Previous studies have revealed that magnesium (Mg) plays a significant role in bone health; however, few studies have investigated the effects of Mg supplementation in diets with different calcium (Ca) levels on the bone status and bone metabolism in a growing stage. In this present study, we tested the effects of Mg supplementation on bone status in growing female rats, relative to Ca intake levels. A total of 40 Sprague-Dawley female rats aged 6 weeks were divided into the following four groups and fed for 12 weeks as indicated: (1) LCaAMg: low Ca (Ca, 0.1 % of total diet) and adequate Mg (Mg, 0.05 % of total diet), (2) LCaHMg: low Ca and high Mg ( Mg, 0.1 % of total diet), (3) ACaAMg: adequate Ca (Ca, 0.5 % of total diet) and adequate Mg, and (4) ACaHMg: adequate Ca and high Mg. Our results showed that Mg supplementation with the adequate Ca diet significantly increased the bone mineral contents, bone size (bone area and bone thickness), and bone mineral density of femur or tibia by improving bone metabolism without changing Ca absorption. Mg supplementation significantly increased the serum osteocalcin in the adequate-Ca-diet group (p
Calcium, vitamin D, vitamin K2, and magnesium supplementation and skeletal health. [2020]Supplementation with calcium (Ca) and/or vitamin D (vitD) is key to the management of osteoporosis. Other supplements like vitamin K2 (VitK2) and magnesium (Mg) could contribute to the maintenance of skeletal health. This narrative review summarizes the most recent data on Ca, vitD, vitK2 and Mg supplementation and age-related bone and muscle loss. Ca supplementation alone is not recommended for fracture prevention in the general postmenopausal population. Patients at risk of fracture with insufficient dietary intake and absorption could benefit from calcium supplementation, but it needs to be customized, taking into account possible side-effects and degree of adherence. VitD supplementation is essential in patients at risk of fracture and/or vitD deficiency. VitK2 and Mg both appear to be involved in bone metabolism. Data suggest that VitK2 supplementation might improve bone quality and reduce fracture risk in osteoporotic patients, potentially enhancing the efficacy of Ca ± vitD. Mg deficiency could negatively influence bone and muscle health. However, data regarding the efficacy of vitK2 and Mg supplementation on bone are inconclusive.
Adequacy Rate of Magnesium Citrate Bowel Preparation in a Large Retrospective Cohort. [2022]Magnesium Citrate (MC) is not FDA approved as a colonoscopy preparation. Advantages include low cost, small volume and accessibility without prescription. We retrospectively evaluated bowel preparations used in a private gastroenterology practice. The sample size is the largest for any similar studies (n =19,173).
Associations of dietary intakes of calcium, magnesium and soy isoflavones with osteoporotic fracture risk in postmenopausal women: a prospective study. [2022]The role of dietary factors in osteoporotic fractures (OFs) in women is not fully elucidated. We investigated the associations between incidence of OF and dietary calcium, magnesium and soy isoflavone intake in a longitudinal study of 48 584 postmenopausal women. Multivariable Cox regression was applied to derive hazard ratios (HRs) and 95 % confidence intervals (CIs) to evaluate associations between dietary intake, based on the averages of two assessments that took place with a median interval of 2⋅4 years, and fracture risk. The average age of study participants is 61⋅4 years (range 43⋅3-76⋅7 years) at study entry. During a median follow-up of 10⋅1 years, 4⋅3 % participants experienced OF. Compared with daily calcium intake ≤400 mg/d, higher calcium intake (>400 mg/d) was significantly associated with about a 40-50 % reduction of OF risk among women with a calcium/magnesium (Ca/Mg) intake ratio ≥1⋅7. Among women with prior fracture history, high soy isoflavone intake was associated with reduced OF risk; the HR was 0⋅72 (95 % CI 0⋅55, 0⋅93) for the highest (>42⋅0 mg/d) v. lowest (<18⋅7 mg/d) quartile intake. This inverse association was more evident among recently menopausal women (<10 years). No significant association between magnesium intake and OF risk was observed. Our findings provide novel information suggesting that the association of OF risk with dietary calcium intake was modified by Ca/Mg ratio, and soy isoflavone intake was modified by history of fractures and time since menopause. Our findings, if confirmed, can help to guide further dietary intervention strategies for OF prevention.