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

NCT06042985 | Unknown Phase 4 DMC

• 1 other identifier: AU-calcium-rct-23
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcium Citrate Absorption; Calcium Carbonate Absorption

Keywords

Calcium Citrate; bariatric surgery; Absorption; Calcium Carbonate

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

RYGB arm: calcium citrate and calcium carbonate

ACTIVE COMPARATOR

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

Drug: The absorption effect between calcium citrate and calcium carbonate

LSG arm: calcium citrate and calcium carbonate

ACTIVE COMPARATOR

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

Drug: The absorption effect between calcium citrate and calcium carbonate

OAGB arm: calcium citrate and calcium carbonate

ACTIVE COMPARATOR

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

Drug: The absorption effect between calcium citrate and calcium carbonate

Interventions

The absorption effect between calcium citrate and calcium carbonate DRUG

Elemental Calcium citrate supplementation will significantly improve patients' absorption after BMS in all cases.

Also known as: Elemental Calcium citrate, Elemental Calcium Carbonate, Chewable tablets

LSG arm: calcium citrate and calcium carbonate; OAGB arm: calcium citrate and calcium carbonate; RYGB arm: calcium citrate and calcium carbonate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, Egypt

Location

Related Publications (5)

• Allied Health Sciences Section Ad Hoc Nutrition Committee; Aills L, Blankenship J, Buffington C, Furtado M, Parrott J. ASMBS Allied Health Nutritional Guidelines for the Surgical Weight Loss Patient. Surg Obes Relat Dis. 2008 Sep-Oct;4(5 Suppl):S73-108. doi: 10.1016/j.soard.2008.03.002. Epub 2008 May 19. No abstract available.

  PMID: 18490202 BACKGROUND

• Mechanick JI, Apovian C, Brethauer S, Garvey WT, Joffe AM, Kim J, Kushner RF, Lindquist R, Pessah-Pollack R, Seger J, Urman RD, Adams S, Cleek JB, Correa R, Figaro MK, Flanders K, Grams J, Hurley DL, Kothari S, Seger MV, Still CD. CLINICAL PRACTICE GUIDELINES FOR THE PERIOPERATIVE NUTRITION, METABOLIC, AND NONSURGICAL SUPPORT OF PATIENTS UNDERGOING BARIATRIC PROCEDURES - 2019 UPDATE: COSPONSORED BY AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS/AMERICAN COLLEGE OF ENDOCRINOLOGY, THE OBESITY SOCIETY, AMERICAN SOCIETY FOR METABOLIC & BARIATRIC SURGERY, OBESITY MEDICINE ASSOCIATION, AND AMERICAN SOCIETY OF ANESTHESIOLOGISTS - EXECUTIVE SUMMARY. Endocr Pract. 2019 Dec;25(12):1346-1359. doi: 10.4158/GL-2019-0406. Epub 2019 Nov 4.

  PMID: 31682518 BACKGROUND

• Tondapu P, Provost D, Adams-Huet B, Sims T, Chang C, Sakhaee K. Comparison of the absorption of calcium carbonate and calcium citrate after Roux-en-Y gastric bypass. Obes Surg. 2009 Sep;19(9):1256-61. doi: 10.1007/s11695-009-9850-6. Epub 2009 May 13.

  PMID: 19437082 BACKGROUND

• Smelt HJ, Pouwels S, Smulders JF. The Clinical Dilemma of Calcium Supplementation After Bariatric Surgery: Calcium Citrate or Calcium Carbonate That Is the Question? Obes Surg. 2016 Nov;26(11):2781-2782. doi: 10.1007/s11695-016-2346-2. No abstract available.

  PMID: 27558620 BACKGROUND

• Schafer AL, Weaver CM, Black DM, Wheeler AL, Chang H, Szefc GV, Stewart L, Rogers SJ, Carter JT, Posselt AM, Shoback DM, Sellmeyer DE. Intestinal Calcium Absorption Decreases Dramatically After Gastric Bypass Surgery Despite Optimization of Vitamin D Status. J Bone Miner Res. 2015 Aug;30(8):1377-85. doi: 10.1002/jbmr.2467. Epub 2015 May 21.

  PMID: 25640580 RESULT

MeSH Terms

Interventions

Calcium Carbonate

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• M Hany Ashour, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M Hany Ashour, MD

CONTACT

+20 100 2600970; mohamed.ashour@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: September 21, 2023
• Study Start: December 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after study completed, for 15 years
• Access Criteria: contact study PI

Locations

EG (1)