Comparison of the Absorption of Calcium Citrate and Calcium Carbonate in Patients With an RYGB, LSG, and OAGB (CALCOR-RSO)

General Committee of Teaching Hospitals and Institutes, Egypt

Status and phase: Not yet enrolling; Phase 4

Conditions: Calcium Carbonate Absorption; Calcium Citrate Absorption

Treatments: Drug: The absorption effect between calcium citrate and calcium carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT06042985

AU-calcium-rct-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150 participants in 3 patient groups

RYGB arm: calcium citrate and calcium carbonate

Active Comparator group

Description:

The absorption effect between calcium citrate and calcium carbonate in patients with a RYGB

Treatment:

Drug: The absorption effect between calcium citrate and calcium carbonate

LSG arm: calcium citrate and calcium carbonate

Active Comparator group

Description:

The absorption effect between calcium citrate and calcium carbonate in patients with a LSG

Treatment:

Drug: The absorption effect between calcium citrate and calcium carbonate

OAGB arm: calcium citrate and calcium carbonate

Active Comparator group

Description:

The absorption effect between calcium citrate and calcium carbonate in patients with a OAGB

Treatment:

Drug: The absorption effect between calcium citrate and calcium carbonate