Monitored vs Standard Supplementation of Vitamin D in Preterm Infants
- Conditions
- OsteopeniaNephrolithiasisDrug OverdoseVitamin D Deficiency
- Interventions
- Dietary Supplement: standard vit D supplementationDietary Supplement: monitored vit D supplementation
- Registration Number
- NCT03087149
- Lead Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description standard group standard vit D supplementation The standard group will receive standard vit D supplementation monitored group monitored vit D supplementation The monitored group will received monitored vit D supplementation
- Primary Outcome Measures
Name Time Method Number of Participants with D- deficiency or access At 52 (+/-2 weeks) PMA (postmenstrual age) 25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Princess Anna Mazowiecka Hospital
🇵🇱Warsaw, Poland