Vitamin D3 DeficiencyViDePrePopNCT04342078
Vitamin D and Health Outcomes in Preterm Born Population
An observational study of Vitamin D3 Deficiency and Prematurity, run by University of Oulu at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 5 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D3 Deficiency, Prematurity, Lung Diseases
- What is being tested?
- Vitamin D
- How many people
- 87 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy preterm born children and young adults. Tern born young adults as controls for the adult group.
Who may be able to join
- preterm and term born adults at the age of 22-25
- preterm born children at 5 years
Who cannot join
- motor disability
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Vitamin D3 Deficiency, Prematurity, Lung Diseases, Heart Rate Variability, Stress Physiology, Bone Diseases, Metabolic
- Being tested
- Vitamin D
- Keywords
- Vitamin D, Prematurity, Bone mineralisation, Lung function, Heart rate, DXA
- Medical subject headings
- Premature Birth, Lung Diseases, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary 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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D of preterm adults, before = VitD 0A
S-25-OH -value; nmol/l
Measured: Baseline
Vitamin D of preterm children = VitD C
S-25-OH -value;nmol/l
Measured: Baseline
Vitamin D of preterm adults, after = VitD 1A
S-25-OH -value; nmol/l
Measured: One year
Exercise heart rate, before = HR 0A
Cycling stress test; heart rate following maximal exercise , seconds to hours
Measured: Baseline
Exercise heart rate, after = HR 1A
Cycling stress test;heart rate following maximal exercise , seconds to hours
Measured: One year
HRV of preterm adults, before = HRV 0A
Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
Measured: Baseline
HRV of preterm adults, after = HRV 1A
Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
Measured: One year
HRV of preterm children = HRV 0C
Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
Measured: Baseline
Lung reversibility test in preterm adults, before = LR 0
Spirometry and bronchodilate test; reversibility: Yes or No
Measured: Baseline
Lung function capacity in preterm adults, before = LFC 0
Spirometry; z-score of FVC
Measured: Baseline
Lung function volume in preterm adults, before = LFV 0
Spirometry ; z-score of FEV1
Measured: Baseline
Lung function capacity in preterm adults, after = LFC 1
Spirometry; z-score of FVC
Measured: One year
Lung function volume in preterm adults, after = LFV 1
Spirometry; z-score of FEV1
Measured: One year
Lung function in preterm children
Auscultation and bronchodilate test; reversibility: Yes or No
Measured: Baseline
Body composition of bone mineral density in preterm adults, before = BMD 0A
DXA result; bone mineral density (BMD) g/cm2; Z-scores
Measured: Baseline
Body composition of bone mineral content in preterm adults, before = BMC 0A
DXA result; bone mineral content (BMC) g; Z-scores
Measured: Baseline
Body composition of bone mineral density in preterm children = BMD C
DXA result; bone mineral density (BMD) g/cm2; Z-scores
Measured: Baseline
Body composition of bone mineral content in preterm children = BMC C
DXA result; bone mineral content (BMC) g; Z-scores
Measured: Baseline
Body composition of bone mineral density in preterm adults, after = BMD 1A
DXA result; bone mineral density (BMD) g/cm2; Z-scores
Measured: One year
Body composition of bone mineral content in preterm adults, after = BMC 1A
DXA result; bone mineral content (BMC) g Z-scores
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Sep 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D3 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marita Valkama, Docent, Study chair, MRC, University of OUluMarja Ojaniemi, Docent, Study director, MRC, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342078
- Sponsor's protocol ID
- EETTMK 92/2017
- Acronym
- ViDePrePop
- Status last verified
- Oct 2023
- First submitted
- 16 May 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04342078
- Acronym / sponsor ID
- ViDePrePop / EETTMK 92/2017
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Dietary Supplement: Vitamin DPreterm born adults at the age of 24-25 years; Born before 34 gestation weeks in 1994-1997; Cared in Oulu University Hospital |
| Adult Control group | – | –Age and gender matched term born controls for comparison of the entry assessments in the Preterm Adult group |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy preterm born children and young adults. Tern born young adults as controls for the adult group.
Key inclusion criteria (2 listed)
- preterm and term born adults at the age of 22-25
- preterm born children at 5 years
Key exclusion criteria (1 listed)
- motor disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DTo 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) | Dietary supplement | Preterm Adult group |
Primary outcome
Vitamin D of preterm adults, before = VitD 0A
Time frame: Baseline
S-25-OH -value; nmol/l
Vitamin D of preterm children = VitD C
Time frame: Baseline
S-25-OH -value;nmol/l
Vitamin D of preterm adults, after = VitD 1A
Time frame: One year
S-25-OH -value; nmol/l
Exercise heart rate, before = HR 0A
Time frame: Baseline
Cycling stress test; heart rate following maximal exercise , seconds to hours
Exercise heart rate, after = HR 1A
Time frame: One year
Cycling stress test;heart rate following maximal exercise , seconds to hours
HRV of preterm adults, before = HRV 0A
Time frame: Baseline
Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
HRV of preterm adults, after = HRV 1A
Time frame: One year
Heart rate variability; autonomic function; heart rate root mean square of the successive differences (RMSSD)
HRV of preterm children = HRV 0C
Time frame: 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
Time frame: Baseline
Spirometry and bronchodilate test; reversibility: Yes or No
Lung function capacity in preterm adults, before = LFC 0
Time frame: Baseline
Spirometry; z-score of FVC
Lung function volume in preterm adults, before = LFV 0
Time frame: Baseline
Spirometry ; z-score of FEV1
Lung function capacity in preterm adults, after = LFC 1
Time frame: One year
Spirometry; z-score of FVC
Lung function volume in preterm adults, after = LFV 1
Time frame: One year
Spirometry; z-score of FEV1
Lung function in preterm children
Time frame: Baseline
Auscultation and bronchodilate test; reversibility: Yes or No
Body composition of bone mineral density in preterm adults, before = BMD 0A
Time frame: Baseline
DXA result; bone mineral density (BMD) g/cm2; Z-scores
Body composition of bone mineral content in preterm adults, before = BMC 0A
Time frame: Baseline
DXA result; bone mineral content (BMC) g; Z-scores
Body composition of bone mineral density in preterm children = BMD C
Time frame: Baseline
DXA result; bone mineral density (BMD) g/cm2; Z-scores
Body composition of bone mineral content in preterm children = BMC C
Time frame: Baseline
DXA result; bone mineral content (BMC) g; Z-scores
Body composition of bone mineral density in preterm adults, after = BMD 1A
Time frame: One year
DXA result; bone mineral density (BMD) g/cm2; Z-scores
Body composition of bone mineral content in preterm adults, after = BMC 1A
Time frame: One year
DXA result; bone mineral content (BMC) g Z-scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marita Valkama, Docent study chair
MRC, University of OUlu
Marja Ojaniemi, Docent study director
MRC, University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D3 Deficiency and Prematurity, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D of preterm adults, before = VitD 0A (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.