Drug Overdose, Nephrolithiasis, Osteopenia, Vitamin D Deficiency
Conditions
Keywords
vitamin D, supplementation, hydroxyvitamin D, pretrem infants, osteopenia
Brief summary
The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is safer and more effective than standard therapy in pretrem infants.
Detailed description
Vitamin D (vit D) deficiency is a risk factor of osteopenia of prematurity, which leads to rickets or decreased bone mass mineral density. Recently multiple studies have been published on vit D adjust biological functions. Dosage, safety and effectiveness of vitD supplementation in preterm infants still remains a controversial topic. We hypothesize that monitored supplementation of vit D is more effective and safer than standard therapy 500IU in preterm infants. The study will be carried out in 138 preterm infants, born at 24-32 week of gestational age (GA) at the Princess Anne's Hospital in Warsaw, Poland. We will determine if monitored supplementation of vit D decreases the incidence of vit D deficiency and/or overdosing at 40 week (GA). For secondary objective we shall assess if monitored therapy reduces the incidence of vit D deficiency and/or overdosing at 35, 52 week (GA), prevalence of osteopenia, low bone mass, nephrocalcinosis and nephrolithiasis.
Interventions
DIETARY_SUPPLEMENTmonitored vit D supplementation
The vit D supplementation dose start from dose 500IU from 7th day of age and is modified based on vit D measurement at 4 week of age for infants born \<30 GA, at 8 week of age for infants born \<26 GA at 35+/-2 weeks PMA(postmenstrual age), +/-at 40+/-2 weeks PMA according to the protocol.
DIETARY_SUPPLEMENTstandard vit D supplementation
The vitamin D supplementation dose is 500IU from 7th day of age.
Sponsors
Medical University of Warsaw
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
No
Inclusion criteria
* Preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound) * In born or admitted to the unit within 48hours from birth. * Randomization within 7 days from birth. * Parental consent. * Mothers willing to return for follow up visits.
Exclusion criteria
* Preterm delivery \>=33 weeks of gestation or term delivery (estimated by ultrasound). * Major congenital abnormalities. * Participation in another trial. * Severe illness at birth deemed incompatible with survival. * Congenital HIV infection. * Total parenteral nutrition \> 14 days. * Cholestasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with D- deficiency or access | at 40 (+/-2 weeks) PMA (postmenstrual age) | 25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| average of bone mass | at 35, 40 (+/-2 weeks) PMA | measurement of speed of sound \[SOS\] in meters per second in the axial transmission mode with a small ultrasound probe along the mid tibia by Sunlight Omnisence 7000 Premier using CRB Probe |
| Number of Participants with hypercalcemia | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) | serum calcium level above 2,75mmol/l |
| Number of Participants with hypercalcuria | at 35, 40, 52 (+/-2 weeks) PMA | urine calcium:creatinine ratio \>3,8mmol/mmol for 0-4 week of age; \>3,5mmol/mmol for 5-8 week of age; \>2,8mmol/mmol for 9-12 week of age; \>2,5mmol/mmol for 13-18 week of age; \>2,2mmol/mmol for \>19 week of age |
| Number of Participants with nephrocalcinosis | at 35, 52 (+/-2 weeks) PMA | nephrocalcinosis detected in ultrasonography examination of kidneys |
| Number of Participants with biochemical markers of osteopenia | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) | ALP\>500IU and serum phosphate level \<1,8mmol/l or ALP\>900IU |
Other
| Measure | Time frame | Description |
|---|---|---|
| Avarage of vitamin D level | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) | 25-hydroxyvitamin D serum level |
| Number of Participants with vitamin D- optimal range | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) | 25-hydroxyvitamin D serum level between 30ng/ml (75nmol/l ) and 50ng/ml (125nmol/l ) |
| Number of Participants with vitamin D- acceptable range | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) | 25-hydroxyvitamin D serum level between 30ng/ml (75nmol/l ) and 80ng/ml (200nmol/l ) |
Countries
Poland
Outcome results
None listed