Vitamin D and Health Outcomes in Preterm Born Population

Lung Diseases Clinical Trial

— ViDePrePop  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04342078
• Other study ID #: EETTMK 92/2017
• Status: Active, not recruiting
• Start date: September 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 87
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

Inclusion Criteria:

• preterm and term born adults at the age of 22-25

• preterm born children at 5 years

Exclusion Criteria:

• motor disability

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Vitamin 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)

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bone mineralisation, before = BM 0	ultrasound; bone speed of sound (SOS) m/sec z-score	Baseline
Other	Bone mineralisation, after = BM 1	ultrasound; bone speed of sound (SOS) m/sec z-score	One year
Primary	Vitamin D of preterm adults, before = VitD 0A	S-25-OH -value; nmol/l	Baseline
Primary	Vitamin D of preterm children = VitD C	S-25-OH -value;nmol/l	Baseline
Primary	Vitamin D of preterm adults, after = VitD 1A	S-25-OH -value; nmol/l	One year
Primary	Exercise heart rate, before = HR 0A	Cycling stress test; heart rate following maximal exercise , seconds to hours	Baseline
Primary	Exercise heart rate, after = HR 1A	Cycling stress test;heart rate following maximal exercise , seconds to hours	One year
Primary	HRV of preterm adults, before = HRV 0A	Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)	Baseline
Primary	HRV of preterm adults, after = HRV 1A	Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)	One year
Primary	HRV of preterm children = HRV 0C	Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)	Baseline
Primary	Lung reversibility test in preterm adults, before = LR 0	Spirometry and bronchodilate test; reversibility: Yes or No	Baseline
Primary	Lung function capacity in preterm adults, before = LFC 0	Spirometry; z-score of FVC	Baseline
Primary	Lung function volume in preterm adults, before = LFV 0	Spirometry ; z-score of FEV1	Baseline
Primary	Lung function capacity in preterm adults, after = LFC 1	Spirometry; z-score of FVC	One year
Primary	Lung function volume in preterm adults, after = LFV 1	Spirometry; z-score of FEV1	One year
Primary	Lung function in preterm children	Auscultation and bronchodilate test; reversibility: Yes or No	Baseline
Primary	Body composition of bone mineral density in preterm adults, before = BMD 0A	DXA result; bone mineral density (BMD) g/cm2; Z-scores	Baseline
Primary	Body composition of bone mineral content in preterm adults, before = BMC 0A	DXA result; bone mineral content (BMC) g; Z-scores	Baseline
Primary	Body composition of bone mineral density in preterm children = BMD C	DXA result; bone mineral density (BMD) g/cm2; Z-scores	Baseline
Primary	Body composition of bone mineral content in preterm children = BMC C	DXA result; bone mineral content (BMC) g; Z-scores	Baseline
Primary	Body composition of bone mineral density in preterm adults, after = BMD 1A	DXA result; bone mineral density (BMD) g/cm2; Z-scores	One year
Primary	Body composition of bone mineral content in preterm adults, after = BMC 1A	DXA result; bone mineral content (BMC) g Z-scores	One year