Calcium Carbonate Absorption, Calcium Citrate Absorption
Conditions
Keywords
Calcium Citrate, bariatric surgery, Absorption, Calcium Carbonate
Brief summary
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.
Detailed description
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.
Interventions
DRUGThe absorption effect between calcium citrate and calcium carbonate
Elemental Calcium citrate supplementation will significantly improve patients' absorption after BMS in all cases.
Sponsors
General Committee of Teaching Hospitals and Institutes, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
All the patients will be used in a cross-over study design. The same patient will be using study drugs A or B and switching in the study to the other drug. 7 days period will be applied for any wash-out or possible carry-over effect.
Intervention model description
In a double-blind-randomization procedure, surgeons, the research team, the laboratory, and the statistical analysis team will be blinded; the patient has no influence and not necessary to be blind.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 18-75 years old * After BMS surgery who had an RYGB, SG, or OAGB operation at least 12 months before the study. * Patients will be selected at random from the hospital's electronic patient system.
Exclusion criteria
* Patients on antacids during the study * Patients onH2 receptor antagonists during the study * Patients on proton pump inhibitors during the study * Patients with a previous oophorectomy, * Liver disease, * Renal disease, * Hypercalcemia, * Hyperthyroidism, * Hypothyroidism who require levothyroxine supplementation (Levothyroxine forms complexes with calcium) * Parathyroid disorders * Use of diuretics, * Use of calcitonin, * Use of corticosteroids, * Use of anabolic steroids, * Use of anticonvulsants within three months of the study * Heavy smokers (\>10 cigarettes/day) * Abusing alcohol (\>70 ml/day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Elemental Calcium effects in blood serum (Peak Plasma Concentration (Cmax)) | 8 hours | 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. |
| Elemental Calcium effects in Urine excretion (time curve (AUC)) | 8 hours | 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. |
| Elemental Calcium effects in blood serum (Area under the plasma concentration) | 8 hours | 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. |
Countries
Egypt
Contacts
Primary ContactM Hany Ashour, MD
Outcome results
None listed