Vitamin D and Health Outcomes in Preterm Born Population

NCT04342078 | Unknown DMC

• 1 other identifier: EETTMK 92/2017
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (20)

• Vitamin D of preterm adults, before = VitD 0A

  S-25-OH -value; nmol/l

  Baseline

• Vitamin D of preterm children = VitD C

  S-25-OH -value;nmol/l

  Baseline

• Vitamin D of preterm adults, after = VitD 1A

  S-25-OH -value; nmol/l

  One year

• Exercise heart rate, before = HR 0A

  Cycling stress test; heart rate following maximal exercise , seconds to hours

  Baseline

• Exercise heart rate, after = HR 1A

  Cycling stress test;heart rate following maximal exercise , seconds to hours

  One year

• HRV of preterm adults, before = HRV 0A

  Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)

  Baseline

• HRV of preterm adults, after = HRV 1A

  Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)

  One year

• HRV of preterm children = HRV 0C

  Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)

  Baseline

• Lung reversibility test in preterm adults, before = LR 0

  Spirometry and bronchodilate test; reversibility: Yes or No

  Baseline

• Lung function capacity in preterm adults, before = LFC 0

  Spirometry; z-score of FVC

  Baseline

• Lung function volume in preterm adults, before = LFV 0

  Spirometry ; z-score of FEV1

  Baseline

• Lung function capacity in preterm adults, after = LFC 1

  Spirometry; z-score of FVC

  One year

• Lung function volume in preterm adults, after = LFV 1

  Spirometry; z-score of FEV1

  One year

• Lung function in preterm children

  Auscultation and bronchodilate test; reversibility: Yes or No

  Baseline

• Body composition of bone mineral density in preterm adults, before = BMD 0A

  DXA result; bone mineral density (BMD) g/cm2; Z-scores

  Baseline

• Body composition of bone mineral content in preterm adults, before = BMC 0A

  DXA result; bone mineral content (BMC) g; Z-scores

  Baseline

• Body composition of bone mineral density in preterm children = BMD C

  DXA result; bone mineral density (BMD) g/cm2; Z-scores

  Baseline

• Body composition of bone mineral content in preterm children = BMC C

  DXA result; bone mineral content (BMC) g; Z-scores

  Baseline

• Body composition of bone mineral density in preterm adults, after = BMD 1A

  DXA result; bone mineral density (BMD) g/cm2; Z-scores

  One year

• Body composition of bone mineral content in preterm adults, after = BMC 1A

  DXA result; bone mineral content (BMC) g Z-scores

  One year

Other Outcomes (2)

• Bone mineralisation, before = BM 0

  Baseline

• Bone mineralisation, after = BM 1

  One year

Study Arms (3)

Preterm Child group

Preterm children at the age of 5 years; Born before 34 gestation weeks in 2014-2017; Cared in Oulu University Hospital

Preterm Adult group

Preterm born adults at the age of 24-25 years; Born before 34 gestation weeks in 1994-1997; Cared in Oulu University Hospital

Dietary Supplement: Vitamin D

Adult Control group

Age and gender matched term born controls for comparison of the entry assessments in the Preterm Adult group

Interventions

Vitamin D DIETARY_SUPPLEMENT

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)

Preterm Adult group

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy preterm born children and young adults. Tern born young adults as controls for the adult group.

You may qualify if:

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

You may not qualify if:

• \- motor disability

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Premature Birth; Lung Diseases; Bone Diseases, Metabolic

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Tract Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Marita Valkama, Docent

  MRC, University of OUlu

  STUDY CHAIR

• Marja Ojaniemi, Docent

  MRC, University of Oulu

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: April 10, 2020
• Study Start: September 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)