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

September 15, 2023 updated by: Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • The surgical department of Medical Research Institute Hospital, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RYGB arm: calcium citrate and calcium carbonate
The absorption effect between calcium citrate and calcium carbonate in patients with a RYGB
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:
  • Elemental Calcium citrate
  • Elemental Calcium Carbonate
  • Chewable tablets
Active Comparator: LSG arm: 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
Elemental Calcium citrate supplementation will significantly improve patients' absorption after BMS in all cases.
Other Names:
  • Elemental Calcium citrate
  • Elemental Calcium Carbonate
  • Chewable tablets
Active Comparator: OAGB arm: 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.
Other Names:
  • Elemental Calcium citrate
  • Elemental Calcium Carbonate
  • 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))
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.
8 hours
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.
8 hours
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.
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Investigators

  • Principal Investigator: M Hany Ashour, MD, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU-calcium-rct-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

after study completed, for 15 years

IPD Sharing Access Criteria

contact study PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Calcium Citrate Absorption

Clinical Trials on The absorption effect between calcium citrate and calcium carbonate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe