Calcium (ca),Phosphorus( P) and 25-hydroxyvitamin D(25OHD)] in Infants Born ≤ 32 PMA Gestational Weeks (GA)
- Conditions
- Infant, Premature, Diseases
- Interventions
- Dietary Supplement: Cholecalciferol 800Dietary Supplement: Cholecalciferol 400
- Registration Number
- NCT03691896
- Lead Sponsor
- Centre of Postgraduate Medical Education
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Higher dose Cholecalciferol 1200 cholecalciferol 1200UNT, oral solution, Middle dose Cholecalciferol 800 cholecalciferol 800UNT, oral solution Lower dose Cholecalciferol 400 cholecalciferol 400UNT, oral solution
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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)
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)
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 P serum levels 4,8,12 weeks of life,1 and 2 years of age assessment of P serum levels in children
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 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 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
correlation of cord blood 25OHD level and GA 1st day of life birth \<24 GA, 24-28GA, 28-32GA
Trial Locations
- Locations (1)
SPSK im. prof. W.Orłowskiego CMKP Neonatology Departament
🇵🇱Warszawa, Mazowieckie, Poland