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

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ClinicalTrials.gov Identifier: NCT03087149
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Medical University of Warsaw
Information provided by (Responsible Party):
Alicja Kołodziejczyk, 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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Osteopenia Nephrolithiasis Drug Overdose Dietary Supplement: monitored vit D supplementation Dietary Supplement: standard vit D supplementation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: monitored group
The monitored group will received monitored vit D supplementation
Dietary Supplement: monitored 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.

Active Comparator: standard group
The standard group will receive standard vit D supplementation
Dietary Supplement: standard vit D supplementation
The vitamin D supplementation dose is 500IU from 7th day of age.




Primary Outcome Measures :
  1. vitamin D- normal range [ Time Frame: at 40 (+/-2 weeks) PMA (postmenstrual age) ]
    25-hydroxyvitamin D serum level between 20ng/ml (50nmol/l ) and 100ng/ml (250nmol/l ) (normal level) and between 25-hydroxyvitamin D serum level between 30-50ng/ml (75-125nmol)- optimal level


Secondary Outcome Measures :
  1. biochemical markers of osteopenia [ Time Frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) ]
    ALP>500IU and serum phosphate level <1,8mmol/l

  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. hypercalcemia [ Time Frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) ]
    serum calcium level above 2,75mmol/l

  4. 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. nephrocalcinosis [ Time Frame: at 35, 52 (+/-2 weeks) PMA ]
    nephrocalcinosis detected in ultrasonography examination of kidneys

  6. 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 )

  7. vitamin D- normal range [ Time Frame: at 35, 52 (+/-2 weeks) PMA (postmenstrual age) ]
    ALP>500IU and serum phosphate level <1,8mmol/l



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087149


Contacts
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Contact: Alicja J Kołodziejczyk 501049246 ext +48 zuzialicja@gmail.com
Contact: Joanna S Seliga-Siwecka, Doctor 502053351 ext +48 seliga.joanna@gmail.com

Locations
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Poland
Princess Anna Mazowiecka Hospital Recruiting
Warsaw, Poland, 00-315
Contact: Maria K Borszewska-Kornacka, Professor    225966155 ext +48    mariak@szpitalkarowa.pl   
Sponsors and Collaborators
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Medical University of Warsaw
Investigators
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Study Chair: Maria K Borszewska-Kornacka, Professor Princess Anna Mazowiecka Hospital

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alicja Kołodziejczyk, PhD student, Princess Anna Mazowiecka Hospital, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT03087149     History of Changes
Other Study ID Numbers: VitD-2016
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alicja Kołodziejczyk, Princess Anna Mazowiecka Hospital, Warsaw, Poland:
vitamin D
supplementation
hydroxyvitamin D
pretrem infants
osteopenia

Additional relevant MeSH terms:
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Vitamin D Deficiency
Bone Diseases, Metabolic
Nephrolithiasis
Kidney Calculi
Drug Overdose
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Substance-Related Disorders
Chemically-Induced Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents