Comparison of the Absorption of Calcium Citrate and Calcium Carbonate in Patients With an RYGB, LSG, and OAGB

Study Overview
=================
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.

Official Title
-----------------
Comparison of the Absorption of Calcium Citrate and Calcium Carbonate in Patients With an RYGB, LSG, and OAGB A Double-blind, Randomized Cross-over Trial

Conditions
-----------------
Calcium Citrate Absorption, Calcium Carbonate Absorption

Intervention / Treatment
-----------------
* Drug: The absorption effect between calcium citrate and calcium carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RYGB arm: calcium citrate and calcium carbonate<br>The absorption effect between calcium citrate and calcium carbonate in patients with a RYGB | Drug: The absorption effect between calcium citrate and calcium carbonate<br>* Elemental Calcium citrate supplementation will significantly improve patients' absorption after BMS in all cases.<br>* Other names: Chewable tablets;|
| Active Comparator: LSG arm: calcium citrate and calcium carbonate<br>The absorption effect between calcium citrate and calcium carbonate in patients with a LSG | Drug: The absorption effect between calcium citrate and calcium carbonate<br>* Elemental Calcium citrate supplementation will significantly improve patients' absorption after BMS in all cases.<br>* Other names: Chewable tablets;|
| Active Comparator: OAGB arm: calcium citrate and calcium carbonate<br>The absorption effect between calcium citrate and calcium carbonate in patients with a OAGB | Drug: The absorption effect between calcium citrate and calcium carbonate<br>* Elemental Calcium citrate supplementation will significantly improve patients' absorption after BMS in all cases.<br>* Other names: Chewable tablets;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcium Citrate, bariatric surgery, Absorption, Calcium Carbonate