Bioavailability and Acceptability of Enteric-Coated Microencapsulated Calcium During Pregnancy: A Randomized Crossover Trial in Bangladesh (Encapsulated Calcium Absorption in Pregnancy)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- Fractional Calcium Absorption
研究概览
简要总结
This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka, Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg, 1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests, one with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium and the other with a micronutrient supplement powder containing encapsulated calcium at the same dose. The absorption tests will be separated by a 2-week washout period. Fractional calcium absorption will be measured using the dual stable isotope method. For each test, the formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable isotope will be given orally and a 42Ca-labeled stable isotope dose will be given intravenously. Urine will be collected for 48 hours to measure calcium absorption.
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
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 to 30 years
- •Current residence in Dhaka at a fixed address
- •Plan to remain in Dhaka for at least 2 months from date of enrolment
- •Gestational age of 27 completed weeks ± 1 week, estimated based on the recalled first day of the last menstrual period (LMP)
排除标准
- •Complicated medical or obstetric history, based on self-report or clinical assessment by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa, threatened abortion, hypertension, preeclampsia, multiple gestation, diabetes, renal disease)
- •Higher risk pregnancy based on one or more of the following clinical findings at time of recruitment:
- •Severe anemia (hemoglobin <70 g/L assessed by Hemocue)
- •Proteinuria (≥ 100 mg/dl based on urine dipstick)
- •Glycosuria (≥ 100 mg/dl based on urine dipstick)
- •Hypertension (systolic blood pressure, ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg)
- •Reported use of dietary supplements that contain >500 mg of calcium per day and/or >400 IU (10 mcg) of vitamin D per day
- •Reported use (chewing) of betel leaf, areca nut and lime (together referred to locally as paan) during pregnancy
结局指标
主要结局
Fractional Calcium Absorption
时间窗: Fractional calcium absorption during day 35-36
The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day).
次要结局
- Palatability and Acceptability(Baseline, +10/11 days, +35/36 days)
研究者
Daniel Roth
Staff Physician, Paediatric Medicine
The Hospital for Sick Children