NCT02621827已完成不适用
Vitamin D Half-life in Pregnancy and Lactation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Plasma concentration of stable isotope labeled 25(OH)D3
研究概览
简要总结
This study measures the plasma half-life of 25-hydroxyvitamin D3 (25(OH)D3) in non-pregnant-non-lactating women, pregnant women at 30 wk gestational age and at 3 months post-partum in women who are exclusively breast-feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All participants:
- •Currently resident in West Kiang and planning to stay for the next 5 months
- •Aged between 18 and 45 y
- •> 20 wk < 30 wk pregnant (gestational age assessment by ultrasound)
- •Singleton fetus
- •Breast feeding
排除标准
- •All participants:
- •Severe anaemia (haemoglobin < 7 g/dL) (as per ENID protocol)
- •Known sickle cell anaemia
- •Known to be asthmatic or allergic to peanuts (already excluded from ENID)
- •Known history of liver, kidney, gut or malabsorption problems
- •Other chronic condition
- •On prescription medication
- •Taking vitamin D supplements (> 200 IU/d)
- •Broken bone in last 3 y
- •Recent infection or illness (2 weeks prior to the start of a study period)
- •Reported onset of menopause (already excluded from ENID)
- •Malaria parasitemia (prior to study period)
- •Unable to consent
- •Pregnancy-related complications or on discretion of mid-wife
- •Known HIV positive
- •Health problem of mother or infant that may affect feeding practices
结局指标
主要结局
Plasma concentration of stable isotope labeled 25(OH)D3
时间窗: Samples collected on day 6, 9, 21, 24, 27 and 30 post-dose
The plasma half-life of 25(OH)D3 is calculated from the slope (k) of the disappearance of the stable isotope labeled 25(OH)D3 against time using the equation half-life=0.693/k
次要结局
- Plasma concentration of vitamin D metabolites and related calciotropic hormones(Fasting plasma samples collected at baseline and 21 days post-dose)
- Urinary concentration of calcium, phosphate, creatinine and cyclic adenosine monophosphate (cAMP)(Samples collected at baseline and 21 days post-dose)
- Weighed dietary intake(2 days within 30 days of dose)
研究者
Kerry Jones
Investigator scientist
Medical Research Council
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