Clinical Trial to Evaluate the Gastric Tolerability and Efficacy of the Food Supplement of Microencapsulated Calcium Carbonate vs Conventional Calcium Carbonate and Calcium Citrate
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Gastric symptoms
研究概览
简要总结
Interventional Clinical trial with food supplement, randomized, double-blind, comparative between microencapsulated calcium, calcium carbonate salts standardized and calcium citrate, in a population of postmenopausal women, lasting 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Women
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal woman
- •Low contribution of elemental calcium in the daily diet
排除标准
- •Hypersensitivity to the active substances or to any of the excipients
- •Renal insufficiency
- •History of kidney or urinary stones
- •Use in the last month of diuretics (furosemide, ethacrynic acid), aluminum salts and / or thyroid hormones
- •Use of any other drug or experimental device during the 30 days prior to the selection
研究组 & 干预措施
Calcium supplement 10/90
Microencapsulated calcium, 1389 mg orally (10% protein and 90% calcium carbonate, corresponding to 500 mg of calcium element per tablet). There will be 2 doses of 1389 mg each orally, to make a total contribution of 1,000 mg. of calcium element.
干预措施: Calcium supplement (Dietary Supplement)
Calcium carbonate supplement
1,250 mg orally (500 mg of calcium element). There will be 2 doses of 1,250 mg. each orally, to make a total contribution of 1,000 mg. of calcium element.
干预措施: Calcium supplement (Dietary Supplement)
Calcium supplement 5/95
Microencapsulated calcium1316 mg orally (5% protein and 95% calcium carbonate, corresponding to 500 mg of calcium element per tablet). There will be 2 shots of 1,316 mg each orally, to make a total contribution of 1,000 mg. calcium element
干预措施: Calcium supplement (Dietary Supplement)
Calcium citrate supplement
1,500 mg orally (315 mg of calcium element). There will be 2 taken orally, to make a total contribution of 945 mg. calcium element
干预措施: Calcium supplement (Dietary Supplement)
结局指标
主要结局
Gastric symptoms
时间窗: 1 month
Using the Gastrointestinal Symptom Rating Scale (GRS). The scale measures constipation, diarrhea, windiness, swelling, nausea, reflux, pain and burning. The patient will have to choose the most appropriate response among those proposed. "Not at all" is the better outcome and "very strong discomfort" is the worst outcome
次要结局
- Changes in bone markers(Basal and 1 month)
研究者
Dr. Santiago Palacios
Principal Investigator
Instituto Palacios