Vitamin D and Health Outcomes in Preterm Born Population
- Conditions
- Lung DiseasesStress PhysiologyPrematurityBone Diseases, MetabolicVitamin D3 DeficiencyHeart Rate Variability
- Interventions
- Dietary Supplement: Vitamin D
- Registration Number
- NCT04342078
- Lead Sponsor
- University of Oulu
- Brief Summary
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).
- Detailed Description
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:
At the first visit and in the end of intervention; measurements of length, weight, head circumference, waist-to-hip ratio will be done; muscular power is assessed by grip test of both hands; lung function test with bronchodilatation is done at the first appointment; heart ultrasound, blood pressure measurement and bicycle stress test with a circadian electrocardiography will be done in the beginning and at the end; bone mineralisation will be measured by dual energy x-ray absorptiometry (DXA) and ultrasound methods; VitD concentration will be measured 4 months interval during the follow up. The control peers participate only the first visit. The child group will be assessed only once and without bicycle stress test.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 87
- preterm and term born adults at the age of 22-25
- preterm born children at 5 years
- motor disability
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Preterm Adult group Vitamin D Preterm born adults at the age of 24-25 years; Born before 34 gestation weeks in 1994-1997; Cared in Oulu University Hospital
- Primary Outcome Measures
Name Time Method Vitamin D of preterm adults, before = VitD 0A Baseline S-25-OH -value; nmol/l
Exercise heart rate, before = HR 0A Baseline Cycling stress test; heart rate following maximal exercise , seconds to hours
Lung function volume in preterm adults, before = LFV 0 Baseline Spirometry ; z-score of FEV1
Lung function capacity in preterm adults, after = LFC 1 One year Spirometry; z-score of FVC
Body composition of bone mineral content in preterm adults, before = BMC 0A Baseline DXA result; bone mineral content (BMC) g; Z-scores
Body composition of bone mineral density in preterm adults, after = BMD 1A One year DXA result; bone mineral density (BMD) g/cm2; Z-scores
Vitamin D of preterm children = VitD C Baseline S-25-OH -value;nmol/l
Vitamin D of preterm adults, after = VitD 1A One year S-25-OH -value; nmol/l
HRV of preterm adults, after = HRV 1A 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 Baseline Spirometry; z-score of FVC
Exercise heart rate, after = HR 1A One year Cycling stress test;heart rate following maximal exercise , seconds to hours
HRV of preterm children = HRV 0C 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 Baseline Spirometry and bronchodilate test; reversibility: Yes or No
Body composition of bone mineral density in preterm children = BMD C Baseline DXA result; bone mineral density (BMD) g/cm2; Z-scores
Body composition of bone mineral content in preterm children = BMC C Baseline DXA result; bone mineral content (BMC) g; Z-scores
HRV of preterm adults, before = HRV 0A 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 One year Spirometry; z-score of FEV1
Body composition of bone mineral content in preterm adults, after = BMC 1A One year DXA result; bone mineral content (BMC) g Z-scores
Body composition of bone mineral density in preterm adults, before = BMD 0A Baseline DXA result; bone mineral density (BMD) g/cm2; Z-scores
Lung function in preterm children Baseline Auscultation and bronchodilate test; reversibility: Yes or No
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oulu University Hospital
🇫🇮Oulu, Finland