Vitamin D DeficiencyMOSVIDNCT03087149

Monitored vs Standard Supplementation of Vitamin D in Preterm Infants

A study testing monitored vit D supplementation and standard vit D supplementation in people with Vitamin D Deficiency and Osteopenia, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 1 day to 7 days
Conditions the study is for: Vitamin D Deficiency, Osteopenia, Nephrolithiasis
What is being tested?: monitored vit D supplementation and standard vit D supplementation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 1 sitePoland
Study dates: 1 May 2017to 31 Mar 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 day to 7 days
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Poland1 site

Princess Anna Mazowiecka Hospital
Warsaw, 00-315

Other trials in Poland

About this study

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

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.

Read the 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.

Conditions: Vitamin D Deficiency, Osteopenia, Nephrolithiasis, Drug Overdose
Being tested: monitored vit D supplementation, standard vit D supplementation
Keywords: vitamin D, supplementation, hydroxyvitamin D, pretrem infants, osteopenia
Medical subject headings: Vitamin D Deficiency, Bone Diseases, Metabolic, Nephrolithiasis, Drug Overdose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

monitored vit D supplementationDietary 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 supplementationDietary supplement
The vitamin D supplementation dose is 500IU from 7th day of age.

Study groups in NCT03087149
Study group	Role	What they receive
monitored group	Experimental	The monitored group will received monitored vit D supplementation Receives: Dietary Supplement: monitored vit D supplementation
standard group	Active comparator	The standard group will receive standard vit D supplementation Receives: Dietary Supplement: standard vit D supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with D- deficiency or access
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Measured: at 40 (+/-2 weeks) PMA (postmenstrual age)
Number of Participants with D- deficiency or access
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Measured: at 4 weeks of age
Number of Participants with D- deficiency or access
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Measured: At 35 (+/-2 weeks) PMA (postmenstrual age)
Number of Participants with D- deficiency or access
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
Measured: At 52 (+/-2 weeks) PMA (postmenstrual age)

Secondary outcomes (5)

Number of Participants with biochemical markers of osteopenia
ALP>500IU and serum phosphate level <1,8mmol/l or ALP>900IU
Measured: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
average of bone mass
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
Measured: at 35, 40 (+/-2 weeks) PMA
Number of Participants with hypercalcemia
serum calcium level above 2,75mmol/l
Measured: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
Number of Participants with hypercalcuria
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
Measured: at 35, 40, 52 (+/-2 weeks) PMA
Number of Participants with nephrocalcinosis
nephrocalcinosis detected in ultrasonography examination of kidneys
Measured: at 35, 52 (+/-2 weeks) PMA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201731 Mar 2020

First posted22 Mar 2017
Study start1 May 2017
Primary completion31 Dec 2019
Study completion31 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03087149
Sponsor's protocol ID: VitD-2016
Acronym: MOSVID
Status last verified: Feb 2021
First submitted: 15 Mar 2017
Last updated: 15 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Backstrom MC, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Kouri T, Maki M. Randomised controlled trial of vitamin D supplementation on bone density and biochemical indices in preterm infants. Arch Dis Child Fetal Neonatal Ed. 1999 May;80(3):F161-6. doi: 10.1136/fn.80.3.f161.
PubMed 10212074
Rigo J, Pieltain C, Salle B, Senterre J. Enteral calcium, phosphate and vitamin D requirements and bone mineralization in preterm infants. Acta Paediatr. 2007 Jul;96(7):969-74. doi: 10.1111/j.1651-2227.2007.00336.x.
PubMed 17577338
Zerofsky M, Ryder M, Bhatia S, Stephensen CB, King J, Fung EB. Effects of early vitamin D deficiency rickets on bone and dental health, growth and immunity. Matern Child Nutr. 2016 Oct;12(4):898-907. doi: 10.1111/mcn.12187. Epub 2015 Apr 7.
PubMed 25850574
Zhu K, Whitehouse AJ, Hart PH, Kusel M, Mountain J, Lye S, Pennell C, Walsh JP. Maternal vitamin D status during pregnancy and bone mass in offspring at 20 years of age: a prospective cohort study. J Bone Miner Res. 2014;29(5):1088-95. doi: 10.1002/jbmr.2138.
PubMed 24189972
Dinlen N, Zenciroglu A, Beken S, Dursun A, Dilli D, Okumus N. Association of vitamin D deficiency with acute lower respiratory tract infections in newborns. J Matern Fetal Neonatal Med. 2016 Mar;29(6):928-32. doi: 10.3109/14767058.2015.1023710. Epub 2015 Mar 19.
PubMed 25786473
Grant CC, Kaur S, Waymouth E, Mitchell EA, Scragg R, Ekeroma A, Stewart A, Crane J, Trenholme A, Camargo CA Jr. Reduced primary care respiratory infection visits following pregnancy and infancy vitamin D supplementation: a randomised controlled trial. Acta Paediatr. 2015 Apr;104(4):396-404. doi: 10.1111/apa.12819. Epub 2014 Oct 21.
PubMed 25283480
Gernand AD, Simhan HN, Caritis S, Bodnar LM. Maternal vitamin D status and small-for-gestational-age offspring in women at high risk for preeclampsia. Obstet Gynecol. 2014 Jan;123(1):40-48. doi: 10.1097/AOG.0000000000000049.
PubMed 24463662
Whitehouse AJ, Holt BJ, Serralha M, Holt PG, Kusel MM, Hart PH. Maternal serum vitamin D levels during pregnancy and offspring neurocognitive development. Pediatrics. 2012 Mar;129(3):485-93. doi: 10.1542/peds.2011-2644. Epub 2012 Feb 13.
PubMed 22331333
Pludowski P, Holick MF, Pilz S, Wagner CL, Hollis BW, Grant WB, Shoenfeld Y, Lerchbaum E, Llewellyn DJ, Kienreich K, Soni M. Vitamin D effects on musculoskeletal health, immunity, autoimmunity, cardiovascular disease, cancer, fertility, pregnancy, dementia and mortality-a review of recent evidence. Autoimmun Rev. 2013 Aug;12(10):976-89. doi: 10.1016/j.autrev.2013.02.004. Epub 2013 Mar 28.
PubMed 23542507
Vogiatzi MG, Jacobson-Dickman E, DeBoer MD; Drugs, and Therapeutics Committee of The Pediatric Endocrine Society. Vitamin D supplementation and risk of toxicity in pediatrics: a review of current literature. J Clin Endocrinol Metab. 2014 Apr;99(4):1132-41. doi: 10.1210/jc.2013-3655. Epub 2014 Jan 23.
PubMed 24456284
Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1.
PubMed 16399151
Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463.
PubMed 21706518
Whitehouse AJ, Holt BJ, Serralha M, Holt PG, Hart PH, Kusel MM. Maternal vitamin D levels and the autism phenotype among offspring. J Autism Dev Disord. 2013 Jul;43(7):1495-504. doi: 10.1007/s10803-012-1676-8.
PubMed 23070790
Cetinkaya M, Cekmez F, Erener-Ercan T, Buyukkale G, Demirhan A, Aydemir G, Aydin FN. Maternal/neonatal vitamin D deficiency: a risk factor for bronchopulmonary dysplasia in preterms? J Perinatol. 2015 Oct;35(10):813-7. doi: 10.1038/jp.2015.88. Epub 2015 Jul 30.
PubMed 26226242
Cizmeci MN, Kanburoglu MK, Akelma AZ, Ayyildiz A, Kutukoglu I, Malli DD, Tatli MM. Cord-blood 25-hydroxyvitamin D levels and risk of early-onset neonatal sepsis: a case-control study from a tertiary care center in Turkey. Eur J Pediatr. 2015 Jun;174(6):809-15. doi: 10.1007/s00431-014-2469-1. Epub 2014 Dec 12.
PubMed 25504199

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Vitamin D Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03087149
Acronym / sponsor ID: MOSVID / VitD-2016
Conditions: Vitamin D Deficiency, Osteopenia, Nephrolithiasis, Drug Overdose
Keywords: vitamin D, supplementation, hydroxyvitamin D, pretrem infants, osteopenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Princess Anna Mazowiecka Hospital, Warsaw, PolandUniversity, hospital or other
Collaborators: Medical University of Warsaw
Study start: 1 May 2017 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Mar 2020 (actual)
First posted: 22 Mar 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
monitored group	Experimental	Dietary Supplement: monitored vit D supplementationThe monitored group will received monitored vit D supplementation
standard group	Active comparator	Dietary Supplement: standard vit D supplementationThe standard group will receive standard vit D supplementation

Who may qualify

Ages: 1 day to 7 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
monitored vit D supplementationThe 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.	Dietary supplement	monitored group
standard vit D supplementationThe vitamin D supplementation dose is 500IU from 7th day of age.	Dietary supplement	standard group

Primary outcome

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 )
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 )
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 )
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 )

5 secondary outcomes

Number of Participants with biochemical markers of osteopenia
Time frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
average of bone mass
Time frame: at 35, 40 (+/-2 weeks) PMA
Number of Participants with hypercalcemia
Time frame: at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age)
Number of Participants with hypercalcuria
Time frame: at 35, 40, 52 (+/-2 weeks) PMA
Number of Participants with nephrocalcinosis
Time frame: at 35, 52 (+/-2 weeks) PMA

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
Background: PubMed 10212074Backstrom MC, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Kouri T, Maki M. Randomised controlled trial of vitamin D supplementation on bone density and biochemical indices in preterm infants. Arch Dis Child Fetal Neonatal Ed. 1999 May;80(3):F161-6. doi: 10.1136/fn.80.3.f161.
Background: PubMed 17577338Rigo J, Pieltain C, Salle B, Senterre J. Enteral calcium, phosphate and vitamin D requirements and bone mineralization in preterm infants. Acta Paediatr. 2007 Jul;96(7):969-74. doi: 10.1111/j.1651-2227.2007.00336.x.
Background: PubMed 25850574Zerofsky M, Ryder M, Bhatia S, Stephensen CB, King J, Fung EB. Effects of early vitamin D deficiency rickets on bone and dental health, growth and immunity. Matern Child Nutr. 2016 Oct;12(4):898-907. doi: 10.1111/mcn.12187. Epub 2015 Apr 7.
Background: PubMed 24189972Zhu K, Whitehouse AJ, Hart PH, Kusel M, Mountain J, Lye S, Pennell C, Walsh JP. Maternal vitamin D status during pregnancy and bone mass in offspring at 20 years of age: a prospective cohort study. J Bone Miner Res. 2014;29(5):1088-95. doi: 10.1002/jbmr.2138.
Background: PubMed 25786473Dinlen N, Zenciroglu A, Beken S, Dursun A, Dilli D, Okumus N. Association of vitamin D deficiency with acute lower respiratory tract infections in newborns. J Matern Fetal Neonatal Med. 2016 Mar;29(6):928-32. doi: 10.3109/14767058.2015.1023710. Epub 2015 Mar 19.
Background: PubMed 25283480Grant CC, Kaur S, Waymouth E, Mitchell EA, Scragg R, Ekeroma A, Stewart A, Crane J, Trenholme A, Camargo CA Jr. Reduced primary care respiratory infection visits following pregnancy and infancy vitamin D supplementation: a randomised controlled trial. Acta Paediatr. 2015 Apr;104(4):396-404. doi: 10.1111/apa.12819. Epub 2014 Oct 21.
Background: PubMed 24463662Gernand AD, Simhan HN, Caritis S, Bodnar LM. Maternal vitamin D status and small-for-gestational-age offspring in women at high risk for preeclampsia. Obstet Gynecol. 2014 Jan;123(1):40-48. doi: 10.1097/AOG.0000000000000049.
Background: PubMed 22331333Whitehouse AJ, Holt BJ, Serralha M, Holt PG, Kusel MM, Hart PH. Maternal serum vitamin D levels during pregnancy and offspring neurocognitive development. Pediatrics. 2012 Mar;129(3):485-93. doi: 10.1542/peds.2011-2644. Epub 2012 Feb 13.
Background: PubMed 23542507Pludowski P, Holick MF, Pilz S, Wagner CL, Hollis BW, Grant WB, Shoenfeld Y, Lerchbaum E, Llewellyn DJ, Kienreich K, Soni M. Vitamin D effects on musculoskeletal health, immunity, autoimmunity, cardiovascular disease, cancer, fertility, pregnancy, dementia and mortality-a review of recent evidence. Autoimmun Rev. 2013 Aug;12(10):976-89. doi: 10.1016/j.autrev.2013.02.004. Epub 2013 Mar 28.
Background: PubMed 24456284Vogiatzi MG, Jacobson-Dickman E, DeBoer MD; Drugs, and Therapeutics Committee of The Pediatric Endocrine Society. Vitamin D supplementation and risk of toxicity in pediatrics: a review of current literature. J Clin Endocrinol Metab. 2014 Apr;99(4):1132-41. doi: 10.1210/jc.2013-3655. Epub 2014 Jan 23.
Background: PubMed 16399151Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1.
Background: PubMed 21706518Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463.
Individual participant dataSharing planned: Yes

Related trials for Vitamin D Deficiency

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria K Borszewska-Kornacka, Professor study chair

Princess Anna Mazowiecka Hospital

Renata Bokiniec, M.D. study director

Princess Anna Mazowiecka Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with D- deficiency or access (time frame: at 40 (+/-2 weeks) PMA (postmenstrual age)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03087149, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.