Clinical trial NCT06042985: Comparison of the Absorption of Calcium Citrate and Calcium Carbonate in Patients With an RYGB, LSG, and OAGB
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Calcium Citrate Absorption
Calcium Carbonate Absorption
Keywords: Calcium Citrate
bariatric surgery
Absorption
Calcium Carbonate
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2023-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Elemental Calcium effects in blood serum (Peak Plasma Concentration (Cmax))
timeFrame: 8 hours
measure: Elemental Calcium effects in Urine excretion (time curve (AUC))
timeFrame: 8 hours
measure: Elemental Calcium effects in blood serum (Area under the plasma concentration)
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: The surgical department of Medical Research Institute Hospital, Alexandria University
Study officials:
affiliation: Alexandria University
name: M Hany Ashour, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.