Comparison of the Absorption of Calcium Citrate and Calcium Carbonate in Patients With an RYGB, LSG, and OAGB (CALCOR-RSO)
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| ClinicalTrials.gov Identifier: NCT06042985 |
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Recruitment Status :
Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Calcium Citrate Absorption Calcium Carbonate Absorption | Drug: The absorption effect between calcium citrate and calcium carbonate | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| 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. |
| Masking: | Single (Participant) |
| 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. |
| Primary Purpose: | Treatment |
| 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 |
| Estimated Study Start Date : | December 1, 2023 |
| Estimated Primary Completion Date : | April 1, 2024 |
| Estimated Study Completion Date : | June 1, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: RYGB arm: calcium citrate and calcium carbonate
The absorption effect between calcium citrate and calcium carbonate in patients with a RYGB
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Drug: The absorption effect between calcium citrate and calcium carbonate
Elemental Calcium citrate supplementation will significantly improve patients' absorption after BMS in all cases.
Other Names:
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Active Comparator: LSG arm: calcium citrate and calcium carbonate
The absorption effect between calcium citrate and calcium carbonate in patients with a LSG
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Drug: The absorption effect between calcium citrate and calcium carbonate
Elemental Calcium citrate supplementation will significantly improve patients' absorption after BMS in all cases.
Other Names:
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Active Comparator: OAGB arm: calcium citrate and calcium carbonate
The absorption effect between calcium citrate and calcium carbonate in patients with a OAGB
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Drug: The absorption effect between calcium citrate and calcium carbonate
Elemental Calcium citrate supplementation will significantly improve patients' absorption after BMS in all cases.
Other Names:
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- Elemental Calcium effects in blood serum (Peak Plasma Concentration (Cmax)) [ Time Frame: 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)) [ Time Frame: 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) [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06042985
| Contact: M Hany Ashour, MD | +20 100 2600970 | mohamed.ashour@alexu.edu.eg |
| Egypt | |
| The surgical department of Medical Research Institute Hospital, Alexandria University | |
| Alexandria, Egypt | |
| Principal Investigator: | M Hany Ashour, MD | Alexandria University |
Other Publications:
| Responsible Party: | Mohamed Hany Ashour, Principal Investigator, General Committee of Teaching Hospitals and Institutes, Egypt |
| ClinicalTrials.gov Identifier: | NCT06042985 |
| Other Study ID Numbers: |
AU-calcium-rct-23 |
| First Posted: | September 21, 2023 Key Record Dates |
| Last Update Posted: | September 21, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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 Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
| Time Frame: | after study completed, for 15 years |
| Access Criteria: | contact study PI |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Calcium Citrate bariatric surgery Absorption Calcium Carbonate |
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Calcium, Dietary Calcium Carbonate Citric Acid Sodium Citrate Calcium Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents |
Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Antacids Gastrointestinal Agents |