Clinical trial NCT03691896: Calcium (ca),Phosphorus( P) and 25-hydroxyvitamin D(25OHD)] in Infants Born ≤ 32 PMA Gestational Weeks (GA)
Official title: The Impact of the Dose of Vitamin D (vitD) on the Metabolism of ca, p and Concentrations of 25OHD, Bone Status and Development of Premature Infants up to 2 Years of Age. Prospective, Randomized, Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infant, Premature, Diseases
Keywords: premature
osteopenia
Vit. D
LBW (low birth weight)
25OHD
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 200
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum 25OHD levels in cord blood in Polish preterm infants
timeFrame: day of labour
Secondary outcomes:
measure: Impact of supplementation of Vit. D during pregnancy on 25OHD serum level in Polish mothers
timeFrame: day of labour
measure: Impact of dosage of Vit D3 (400/800/1200 UNT per day) on serum 25OH D levels in preterm children
timeFrame: 4,8,12 weeks of life,1 and 2 years of age
measure: Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on Ca serum levels
timeFrame: 4,8,12 weeks of life,1 and 2 years of age
measure: Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on P serum levels
timeFrame: 4,8,12 weeks of life,1 and 2 years of age
measure: Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary Ca excretion
timeFrame: 4,8,12 weeks of life,1 and 2 years of age
measure: Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary P excretion
timeFrame: 4,8,12 weeks of life,1 and 2 years of age
measure: impact of total annual Vit D3 dose and bone calcification in children
timeFrame: average of 1 and 2 years of age
measure: correlation of cord blood 25OHD level and GA
timeFrame: 1st day of life
measure: impact of cord blood 25OHD level on birth weight
timeFrame: 1st day of life of age
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: SPSK im. prof. W.Orłowskiego CMKP Neonatology Departament
state: Mazowieckie
Study officials:
affiliation: Mc postgraduate SPSK im prof.W.Orłowskiego Warszawa
name: Magdalena Zarlenga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mc postgraduate SPSK im prof.W.Orłowskiego Warszawa
name: Maria Wilińska, DSc
role: STUDY_CHAIR
affiliation: Mc postgraduate SPSK im prof.W.Orłowskiego Warszawa
name: Ewa Głuszczak-Idziakowska, PhD
role: PRINCIPAL_INVESTIGATOR
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