Monitored vs Standard Supplementation of Vitamin D in Preterm Infants (MOSVID)

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Status: Completed

Conditions: Osteopenia; Vitamin D Deficiency; Nephrolithiasis; Drug Overdose

Treatments: Dietary Supplement: monitored vit D supplementation; Dietary Supplement: standard vit D supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03087149

VitD-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

monitored group

Experimental group

Description:

The monitored group will received monitored vit D supplementation

Treatment:

Dietary Supplement: monitored vit D supplementation

standard group

Active Comparator group

Description:

The standard group will receive standard vit D supplementation

Treatment:

Dietary Supplement: standard vit D supplementation