Infant, Premature, Diseases
Conditions
Keywords
premature, osteopenia, Vit. D, LBW (low birth weight), 25OHD
Brief summary
It has not yet been established the optimal dose of vit. D for preterm infants in Poland. It is not known what dose of vit. D will provide the correct concentration of vit. D and the optimal development of the skeleton of the premature. The study will try to determine the optimal supplementation of vitamin D and the supply of Ca and P for normal growth and development of a child born prematurely. In addition, the investigators will evaluate any risk factors for deficiency and excess of vitamin D and the consequences of its deficiency and overdose. Simultaneously the study would make possible the determination of an optimal schedule for controlling the Ca-P levels in the group of the youngest infants born prematurely. In addition, the study will assess the relationship between maternal and newborn vitamin D resources right after birth, and the incidence of vitamin D deficiency in infants born prematurely. Preterm infants will be randomized in 3 groups assigned to different doses of vit. D. The study will investigate the metabolism of calcium, phosphorus, the health of bones and development of the premature babies till the age of 2.
Detailed description
The participants of the study will be prematures, born ≤32 GA, hospitalized in the Department of Neonatology, in the neonatal intensive care unit. Hospitalized patients who meet the inclusion criteria will be randomized in 3 groups assigned to different doses of vit. D (400, 800 or 1200 units(UNT) of vitamin D). At defined age points of postnatal life, parameters of calcium and phosphorus metabolism and vitamin D level will be tested, along with the health of bones, health status and development.
Interventions
DIETARY_SUPPLEMENTCholecalciferol 400
dose 400 UNT/day for 12 months
DIETARY_SUPPLEMENTCholecalciferol 800
dose 800 UNT/day for 12 months
DRUGCholecalciferol 1200
dose 1200 UNT/day for 12 months
Sponsors
Centre of Postgraduate Medical Education
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* gestational age ≤32 weeks at birth * hospitalization in the department no later than at the age of 7 days (for infants born outside the center) * No birth defects or diseases permanently affecting the ability to accept enteral feeding * Anticipated possibility of continuous monitoring of the course of treatment in hospital until discharge * Consent of Parents / legal guardians for the participation in the study.
Exclusion criteria
* gestational age\> 32 weeks at birth * the beginning of hospitalization in the department later than the age of 7 days (for infants born outside the center) * presence of congenital defects or diseases permanently affecting the ability to accept enteral feeding (e.g.oesophageal atresia, anal atresia, congenital umbilical hernia, gastroschisis, syndromes genetically determined) * significant interruption (\> 1 week) of the hospitalization in the center * lack of consent of the Parents / legal guardians to participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum 25OHD levels in cord blood in Polish preterm infants | day of labour | assessment of 25OH D levels in children deficiency: \<10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of dosage of Vit D3 (400/800/1200 UNT per day) on serum 25OH D levels in preterm children | 4,8,12 weeks of life,1 and 2 years of age | assessment of serum 25OH D levels in children deficiency: \<10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml; high level \> 60ng/ml, toxic level \> 100ng/ml |
| Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on Ca serum levels | 4,8,12 weeks of life,1 and 2 years of age | assessment of Ca serum levels in children |
| Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on P serum levels | 4,8,12 weeks of life,1 and 2 years of age | assessment of P serum levels in children |
| Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary Ca excretion | 4,8,12 weeks of life,1 and 2 years of age | assessment of urinary calcium/creatinine index |
| Impact of supplementation of Vit. D during pregnancy on 25OHD serum level in Polish mothers | day of labour | assessment of 25OH D levels in mothers deficiency: \<10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml |
| impact of total annual Vit D3 dose and bone calcification in children | average of 1 and 2 years of age | assessment of bone status :Densitometry (DEXA) |
| correlation of cord blood 25OHD level and GA | 1st day of life | birth \<24 GA, 24-28GA, 28-32GA |
| impact of cord blood 25OHD level on birth weight | 1st day of life of age | assessment of percentile of birth weight (Fenton 2013) hypotrophy \<3p, eutrophy 3-97p, hypertrophy \>97p |
| Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary P excretion | 4,8,12 weeks of life,1 and 2 years of age | assessment of urinary P/creatinine index (mg/mg) |
Countries
Poland
Contacts
Primary ContactMagdalena Zarlenga, MD
Backup ContactMaria Wilińska, DSc
Outcome results
None listed