Skip to main content
OpenTrials
Completed

NCT Number: NCT03087149

Monitored vs Standard Supplementation of Vitamin D in Preterm Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

monitored vit D supplementation

Dietary Supplement

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.

standard vit D supplementation

Dietary Supplement

The vitamin D supplementation dose is 500IU from 7th day of age.

Primary outcomes

  1. Number of Participants with D- deficiency or access

    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 )

  2. Number of Participants with D- deficiency or access

    Time frame: at 4 weeks of age

    25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )

  3. Number of Participants with D- deficiency or access

    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 )

  4. Number of Participants with D- deficiency or access

    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 )

Secondary outcomes

  1. Number of Participants with biochemical markers of osteopenia

    Time frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)

    ALP>500IU and serum phosphate level <1,8mmol/l or ALP>900IU

  2. average of bone mass

    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

  3. Number of Participants with hypercalcemia

    Time frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)

    serum calcium level above 2,75mmol/l

  4. Number of Participants with hypercalcuria

    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

  5. Number of Participants with nephrocalcinosis

    Time frame: at 35, 52 (+/-2 weeks) PMA

    nephrocalcinosis detected in ultrasonography examination of kidneys

Other outcomes

  1. Number of Participants with vitamin D- acceptable range

    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 )

  2. Number of Participants with vitamin D- optimal range

    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 )

  3. Avarage of vitamin D level

    Time frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)

    25-hydroxyvitamin D serum level

Sponsors and collaborators

Lead sponsor

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Other

Collaborators

  • Medical University of Warsaw

Registry information

Official study title

Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial

Acronym: MOSVID

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 22, 2017
Registry last updated
Feb 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.