A Phase 4 interventional study of The absorption effect between calcium citrate and calcium carbonate in Calcium Citrate Absorption and Calcium Carbonate Absorption, sponsored by General Committee of Teaching Hospitals and Institutes, Egypt. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by General Committee of Teaching Hospitals and Institutes, Egypt · Phase 4, Interventional, and Treatment
The precise impact of calcium absorption in relation to RYGB, SG, and OAGB remains under-researched in terms of statistical power and the diversity of BMS procedures considered. Therefore, this presents a critical area for future investigation to improve patient outcomes in BMS.
Calcium, predominantly absorbed in the duodenum and proximal jejunum, relies heavily on vitamin D and an acidic environment to facilitate absorption. With the increasing prevalence of bariatric metabolic surgery (BMS) procedures and their malabsorptive effects, the likelihood of fat-soluble vitamin malabsorption becomes heightened. This stems from bypassing the stomach, key absorption sites in the intestine, and the inefficient mixing of bile salts.
BMS is often associated with several bone metabolism disorders, including the acceleration of bone remodeling and turnover, bone loss, and decreased bone mineral density (BMD). Postoperative calcium supplementation can mitigate this bone loss over time. For instance, a study demonstrated the beneficial effect of calcium citrate following Roux-en-Y gastric bypass (RYGB). However, the study's statistical power was insufficient; thus, the BMS field still awaits further conclusive and robust research to establish definitive guidelines, which was highlighted in another study.
Moreover, substantial changes in gut hormones, such as peptide YY (PYY), glucagon-like peptide-1, and ghrelin, have been observed following RYGB, sleeve gastrectomy (SG), and One Anastomosis Gastric Bypass (OAGB). While these hormonal changes are typically associated with BMS's numerous positive metabolic benefits, they may also contribute to bone loss.
Consequently, the precise impact of calcium absorption in relation to RYGB, SG, and OAGB remains under-researched in terms of statistical power and the diversity of BMS procedures considered. Therefore, this presents a critical area for future investigation to improve patient outcomes in BMS.
General Committee of Teaching Hospitals and Institutes, Egypt is the lead sponsor of 31 studies on the registry; 11 are open to participants now.
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The absorption effect between calcium citrate and calcium carbonate in patients with a RYGB
Drug: The absorption effect between calcium citrate and calcium carbonate
The absorption effect between calcium citrate and calcium carbonate in patients with a LSG
Drug: The absorption effect between calcium citrate and calcium carbonate
The absorption effect between calcium citrate and calcium carbonate in patients with a OAGB
Drug: The absorption effect between calcium citrate and calcium carbonate
Elemental Calcium citrate supplementation will significantly improve patients' absorption after BMS in all cases.
Also known as: Elemental Calcium citrate, Elemental Calcium Carbonate, Chewable tablets
Elemental Calcium effects in blood serum (Peak Plasma Concentration (Cmax))
In patients who have undergone bariatric surgery and are receiving elemental calcium supplementation in the form of citrate or carbonate, we observe variations in their blood serum with peak concentrations (Cmax) These changes provide insights into how effectively the body absorbs and utilizes calcium following supplementation.
Time frame: 8 hours
Elemental Calcium effects in Urine excretion (time curve (AUC))
In patients who have undergone bariatric surgery and are receiving elemental calcium supplementation in the form of citrate or carbonate, we observe variations in their cumulative excretion of urinary calcium over time (AUC). These changes provide insights into how effectively the body absorbs and utilizes calcium following supplementation.
Time frame: 8 hours
Elemental Calcium effects in blood serum (Area under the plasma concentration)
In patients who have undergone bariatric surgery and are receiving elemental calcium supplementation in the form of citrate or carbonate, we observe variations in their blood serum with Area under the plasma concentration (AUC) These changes provide insights into how effectively the body absorbs and utilizes calcium following supplementation.
Time frame: 8 hours
Plan to share: Yes — The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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General Committee of Teaching Hospitals and Institutes, Egypt