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临床试验/NCT06042985
NCT06042985尚未招募4 期

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

General Committee of Teaching Hospitals and Institutes, Egypt1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Elemental Calcium effects in blood serum (Peak Plasma Concentration (Cmax))

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

研究组 & 干预措施

RYGB arm: calcium citrate and calcium carbonate

Active Comparator

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

干预措施: The absorption effect between calcium citrate and calcium carbonate (Drug)

LSG arm: calcium citrate and calcium carbonate

Active Comparator

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

干预措施: The absorption effect between calcium citrate and calcium carbonate (Drug)

OAGB arm: calcium citrate and calcium carbonate

Active Comparator

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

干预措施: The absorption effect between calcium citrate and calcium carbonate (Drug)

结局指标

主要结局

Elemental Calcium effects in blood serum (Peak Plasma Concentration (Cmax))

时间窗: 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))

时间窗: 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)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
General Committee of Teaching Hospitals and Institutes, Egypt
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed Hany Ashour

Principal Investigator

General Committee of Teaching Hospitals and Institutes, Egypt

研究点 (1)

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