Princess Anna Mazowiecka Hospital
Warsaw, 00-315, Poland
NCT Number: NCT03087149
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.
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All sexes
Interventional
Not applicable
Warsaw, 00-315, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The vitamin D supplementation dose is 500IU from 7th day of age.
Time frame: at 40 (+/-2 weeks) PMA (postmenstrual age)
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Time frame: at 4 weeks of age
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Time frame: At 35 (+/-2 weeks) PMA (postmenstrual age)
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Time frame: At 52 (+/-2 weeks) PMA (postmenstrual age)
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Time frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
ALP>500IU and serum phosphate level <1,8mmol/l or ALP>900IU
Time frame: 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
Time frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
serum calcium level above 2,75mmol/l
Time frame: 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
Time frame: at 35, 52 (+/-2 weeks) PMA
nephrocalcinosis detected in ultrasonography examination of kidneys
Time frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
25-hydroxyvitamin D serum level between 30ng/ml (75nmol/l ) and 80ng/ml (200nmol/l )
Time frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
25-hydroxyvitamin D serum level between 30ng/ml (75nmol/l ) and 50ng/ml (125nmol/l )
Time frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
25-hydroxyvitamin D serum level
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Other
Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial
Acronym: MOSVID
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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