Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Goals:
Subjects:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Adult Control group | Age and gender matched term born controls for comparison of the entry assessments in the Preterm Adult group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineralisation, before = BM 0 | ultrasound; bone speed of sound (SOS) m/sec z-score | Baseline |
| Bone mineralisation, after = BM 1 | ultrasound; bone speed of sound (SOS) m/sec z-score |
Inclusion Criteria:
Exclusion Criteria:
- motor disability
Not provided
Not provided
Healthy preterm born children and young adults. Tern born young adults as controls for the adult group.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marita Valkama, Docent | MRC, University of OUlu | Study Chair |
| Marja Ojaniemi, Docent | MRC, University of Oulu | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Oulu | 90220 | Finland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D008171 | Lung Diseases |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
serum
|
| 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 |
| One year |
| D000091642 | Urogenital Diseases |
| D012140 | Respiratory Tract Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |