Skip to content

Vitamin D and Health Outcomes in Preterm Born Population

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04342078
Acronym
ViDePrePop
Enrollment
87
Registered
2020-04-10
Start date
2018-09-01
Completion date
2023-12-31
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Diseases, Metabolic, Heart Rate Variability, Lung Diseases, Prematurity, Stress Physiology, Vitamin D3 Deficiency

Keywords

Vitamin D, Prematurity, Bone mineralisation, Lung function, Heart rate, DXA

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.

Interventions

DIETARY_SUPPLEMENTVitamin D

To investigate the effect of one year vitamin D supplementation in preterm born adults (4000 IU = 100 micrograms a day if serum concentration is \< 30 nmol/l, 2000 IU = 50 micrograms a day if 30-50 nmol/l and 1000 IU = 25 micrograms a day if \> 50-80 nmol/l, and no additional supplement if \> 80 nmol/l) on health outcomes (bones, teeth, muscles, heart, lungs) . The target level of vitamin D concentration by every 4 months interval is 80 - 120 nmol/l .(Preterm Adult group)

Sponsors

University of Oulu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* preterm and term born adults at the age of 22-25 * preterm born children at 5 years

Exclusion criteria

\- motor disability

Design outcomes

Primary

MeasureTime frameDescription
Body composition of bone mineral content in preterm adults, after = BMC 1AOne yearDXA result; bone mineral content (BMC) g Z-scores
Body composition of bone mineral content in preterm children = BMC CBaselineDXA result; bone mineral content (BMC) g; Z-scores
Body composition of bone mineral density in preterm adults, after = BMD 1AOne yearDXA result; bone mineral density (BMD) g/cm2; Z-scores
Vitamin D of preterm adults, before = VitD 0ABaselineS-25-OH -value; nmol/l
Vitamin D of preterm children = VitD CBaselineS-25-OH -value;nmol/l
Vitamin D of preterm adults, after = VitD 1AOne yearS-25-OH -value; nmol/l
Exercise heart rate, before = HR 0ABaselineCycling stress test; heart rate following maximal exercise , seconds to hours
Exercise heart rate, after = HR 1AOne yearCycling stress test;heart rate following maximal exercise , seconds to hours
HRV of preterm adults, before = HRV 0ABaselineHeart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
HRV of preterm adults, after = HRV 1AOne yearHeart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
HRV of preterm children = HRV 0CBaselineHeart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
Lung reversibility test in preterm adults, before = LR 0BaselineSpirometry and bronchodilate test; reversibility: Yes or No
Lung function capacity in preterm adults, before = LFC 0BaselineSpirometry; z-score of FVC
Lung function volume in preterm adults, before = LFV 0BaselineSpirometry ; z-score of FEV1
Lung function capacity in preterm adults, after = LFC 1One yearSpirometry; z-score of FVC
Lung function volume in preterm adults, after = LFV 1One yearSpirometry; z-score of FEV1
Lung function in preterm childrenBaselineAuscultation and bronchodilate test; reversibility: Yes or No
Body composition of bone mineral density in preterm adults, before = BMD 0ABaselineDXA result; bone mineral density (BMD) g/cm2; Z-scores
Body composition of bone mineral content in preterm adults, before = BMC 0ABaselineDXA result; bone mineral content (BMC) g; Z-scores
Body composition of bone mineral density in preterm children = BMD CBaselineDXA result; bone mineral density (BMD) g/cm2; Z-scores

Other

MeasureTime frameDescription
Bone mineralisation, after = BM 1One yearultrasound; bone speed of sound (SOS) m/sec z-score
Bone mineralisation, before = BM 0Baselineultrasound; bone speed of sound (SOS) m/sec z-score

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026