Vitamin D and Health Outcomes in Preterm Born Population -A Cohort and an Intervention Study of Vitamin D on Health Outcomes of Bones, Teeth, Muscles, Heart, and Lungs in Children and Adults Born Preterm in Northern Finland
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Vitamin D of preterm adults, before = VitD 0A
研究概览
简要总结
Improved survival of very preterm newborn population during the last decades has challenged us neonatologists to study and improve nutritional practices including vitamin D (VitD) supplementation. However, long term outcome in this aspect has not been researched in well documented preterm populations. As VitD has receptors in almost all human cells it modulates growth of many organs. Therefore I start to assess VitD supplementation practices and later health outcome (bones, teeth, muscles, heart, lungs) in two preterm population cohorts cared in Oulu University Hospital at the age of 5 years and 24 years (born 2014-2017 and 1994-1997).
详细描述
Goals:
- To investigate the impact of VitD and mineral supplementation and biochemistry in infancy on health outcomes at the age of 5 years in childhood (bones, teeth, muscles, heart, lungs) after preterm birth (Preterm Child group)
- To investigate the impact of VitD and mineral supplementation and biochemistry in infancy on health outcomes at the age of 24-25 years in adulthood (bones, teeth, muscles, heart, lungs) after preterm birth (Preterm Adult group)
Subjects:
- Preterm Child group; Children, who were born prematurely before before 32 gestation weeks and before 34 gestation weeks with very low birth weight (VLBW, < 1500g) in Oulu University Hospital and/or cared in Neonatal Unit with VitD concentration measured before discharge during the years 2014 to 2017.
- Preterm Adult group; Adults, who were born prematurely before 32 gestation weeks and before 34 gestation weeks with very low birth weight (VLBW, < 1500g) in Oulu University Hospital and/or cared in Neonatal Intensive Unit during the years 1994 to 1997. For power calculation, the amount of participants for the adult group was done by estimating the inadequately low vitamin D concentration (< 50 nmol/l) to be found in 28 % of preterm born adults. (In Northern Finnish birth cohort 28 % at the age of 31 had serum 25-OH vitamin D concentration < 50 nmol/l in 1997). With the estimation of supplementation to decrease the percentage of participants with low vitamin D to 9 %, the required amount of participants would be minimum of 56 per group. Furthermore, if the level after supplementation is estimated to be low only in 2,8 %, the amount would be required as 29 cases per group.
Methods in protocol:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •preterm and term born adults at the age of 22-25
- •preterm born children at 5 years
排除标准
- •motor disability
结局指标
主要结局
Vitamin D of preterm adults, before = VitD 0A
时间窗: Baseline
S-25-OH -value; nmol/l
Exercise heart rate, before = HR 0A
时间窗: Baseline
Cycling stress test; heart rate following maximal exercise , seconds to hours
Lung function volume in preterm adults, before = LFV 0
时间窗: Baseline
Spirometry ; z-score of FEV1
Lung function capacity in preterm adults, after = LFC 1
时间窗: One year
Spirometry; z-score of FVC
Body composition of bone mineral content in preterm adults, before = BMC 0A
时间窗: Baseline
DXA result; bone mineral content (BMC) g; Z-scores
Body composition of bone mineral density in preterm adults, after = BMD 1A
时间窗: One year
DXA result; bone mineral density (BMD) g/cm2; Z-scores
Vitamin D of preterm children = VitD C
时间窗: Baseline
S-25-OH -value;nmol/l
Vitamin D of preterm adults, after = VitD 1A
时间窗: One year
S-25-OH -value; nmol/l
HRV of preterm adults, after = HRV 1A
时间窗: One year
Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
Lung function capacity in preterm adults, before = LFC 0
时间窗: Baseline
Spirometry; z-score of FVC
Exercise heart rate, after = HR 1A
时间窗: One year
Cycling stress test;heart rate following maximal exercise , seconds to hours
HRV of preterm children = HRV 0C
时间窗: Baseline
Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
Lung reversibility test in preterm adults, before = LR 0
时间窗: Baseline
Spirometry and bronchodilate test; reversibility: Yes or No
Body composition of bone mineral density in preterm children = BMD C
时间窗: Baseline
DXA result; bone mineral density (BMD) g/cm2; Z-scores
HRV of preterm adults, before = HRV 0A
时间窗: Baseline
Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
Lung function volume in preterm adults, after = LFV 1
时间窗: One year
Spirometry; z-score of FEV1
Body composition of bone mineral content in preterm adults, after = BMC 1A
时间窗: One year
DXA result; bone mineral content (BMC) g Z-scores
Body composition of bone mineral density in preterm adults, before = BMD 0A
时间窗: Baseline
DXA result; bone mineral density (BMD) g/cm2; Z-scores
Lung function in preterm children
时间窗: Baseline
Auscultation and bronchodilate test; reversibility: Yes or No
Body composition of bone mineral content in preterm children = BMC C
时间窗: Baseline
DXA result; bone mineral content (BMC) g; Z-scores
次要结局
未报告次要终点