Premature InfantsNCT01469650
Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
A study testing cholecalciferal and cholecalciferol in people with Premature Infants, run by University of Nebraska at 1 site in United States.
Trial summary
This study will determine levels of vitamin D supplementation to achieve goal serum 25-hydroxy vitamin D [25(OH)D] levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in Newborn Intensive Care Nursery (NICU). Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Premature Infants
- What is being tested?
- cholecalciferal and cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 2013
- 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 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- NICU hospitalized infants
- 23-32 weeks gestation
Who cannot join
- congential anomalies
- disorders of calcium metabolism
- inborn error of metabolism
- kidney disease
- liver disease
- use of steroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
This study will determine levels of vitamin D supplementation to achieve goal serum 25-hydroxy vitamin D [25(OH)D] levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in Newborn Intensive Care Nursery (NICU). Infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day.
Read the detailed description
The specific aims of this study are to determine levels of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the Nebraska Medical Center Newborn Intensive Care Nursery (NICU). In this randomized, controlled trial, infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day. As an exploratory aim, vitamin D binding protein levels (VDBP) will also be quantified in these infants.
- Conditions
- Premature Infants
- Being tested
- cholecalciferal, cholecalciferol
- Keywords
- vitamin D3, prematurity, parathyroid hormone, 25(OH)D, NICU hospitalization
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferalDietary supplement
Also called vitamin D3
400 IU/day
cholecalciferolDietary supplement
Also called vitamin D3
800 IU/day D3
| Study group | Role | What they receive |
|---|---|---|
| 400 IU/day vitamin D | Active comparator | Subjects will receive 400 IU/day of vitamin D3, as per current unit policy Receives: Dietary Supplement: cholecalciferal |
| 800 IU/day vitamin D3 | Experimental | Subjects will receive 800 IU/day vitamin D3 Receives: Dietary Supplement: cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-hydroxy vitamin D [25(OH)D] Levels
Serum 25-hydroxy vitamin D [25(OH)D] levels will be compared between the two groups, vitamin D supplementation of 400 IU vitamin D3/day, or 800 IU vitamin D3/day. The specific aims of this study are to determine leves of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL.
Measured: 1 year
Secondary outcomes (1)
Parathyroid Hormone Levels
Parathyroid hormone levels will be compared in between the two groups, vitamin D supplementation of 400 IU vitamin D3/day, or 800 IU vitamin D3/day.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature InfantsStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corrine K Hanson, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469650
- Sponsor's protocol ID
- 0419-11-FB
- Status last verified
- Sep 2023
- First submitted
- 8 Nov 2011
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
PubMed 33305842
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
- ClinicalTrials.gov ID
- NCT01469650
- Acronym / sponsor ID
- 0419-11-FB
- Conditions
- Premature Infants
- Keywords
- vitamin D3, prematurity, parathyroid hormone, 25(OH)D, NICU hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Nov 2011 (estimated)
- 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.
This study will determine levels of vitamin D supplementation to achieve goal serum 25-hydroxy vitamin D [25(OH)D] levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in Newborn Intensive Care Nursery (NICU). Infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day.
Detailed description
The specific aims of this study are to determine levels of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the Nebraska Medical Center Newborn Intensive Care Nursery (NICU). In this randomized, controlled trial, infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day. As an exploratory aim, vitamin D binding protein levels (VDBP) will also be quantified in these infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 IU/day vitamin D | Active comparator | Dietary Supplement: cholecalciferalSubjects will receive 400 IU/day of vitamin D3, as per current unit policy |
| 800 IU/day vitamin D3 | Experimental | Dietary Supplement: cholecalciferolSubjects will receive 800 IU/day vitamin D3 |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- NICU hospitalized infants
- 23-32 weeks gestation
Key exclusion criteria (6 listed)
- congential anomalies
- disorders of calcium metabolism
- inborn error of metabolism
- kidney disease
- liver disease
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 |
|---|---|---|
| cholecalciferalAlso: vitamin D3400 IU/day | Dietary supplement | 400 IU/day vitamin D |
| cholecalciferolAlso: vitamin D3800 IU/day D3 | Dietary supplement | 800 IU/day vitamin D3 |
Primary outcome
Serum 25-hydroxy vitamin D [25(OH)D] Levels
Time frame: 1 year
Serum 25-hydroxy vitamin D [25(OH)D] levels will be compared between the two groups, vitamin D supplementation of 400 IU vitamin D3/day, or 800 IU vitamin D3/day. The specific aims of this study are to determine leves of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL.
1 secondary outcome
Parathyroid Hormone Levels
Time frame: 1 year
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 6 Sep 2023.
- Derived from this study: PubMed 33305842Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
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Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
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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.
Corrine K Hanson, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecalciferal and cholecalciferol in people with Premature Infants, run by University of Nebraska at 1 site in United States.
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 2 inclusion and 6 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 6 Sep 2023. 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 United States. 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?
Serum 25-hydroxy vitamin D [25(OH)D] Levels (time frame: 1 year). 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 NCT01469650, which also lists 1 linked publication.
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 6 Sep 2023.