Vitamin DNCT01042561
Vitamin D Status and Dose Response in Infants
A study testing Vitamin D3 in people with Vitamin D and Prematurity, run by University of Nebraska at 1 site in United States.
Trial summary
This study will examine the relationship of serum 25(OH)D levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism. Read more about this study
- Who is it for?
- Ages 5 minutes to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D, Prematurity
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2009to 1 Aug 2010
- 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 5 minutes to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- greater than 32 weeks gestation,
- exclusively formula fed.
Who cannot join
- less than 32 weeks gestation,
- less than 1500 grams,
- recieving maternal breast milk,
- recieving parenteral nutrition,
- congenital anomolies,
- disorders of vitamin D metabolism,
Show all 11Show fewer
- inborn errors of metabolism,
- seizure disorders,
- parathroid disease,
- liver, GI tract, or kidney disease, and
- disorders of calcium metabolism.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
This study will examine the relationship of serum 25(OH)D levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism.
Read the detailed description
It is hypothesized that serum 25(OH)D levels in infants 32 weeks and greater gestation are not maintained at optimal levels of greater than 32 ng/Ml with currently available infant formulas, and that this will have an inverse relationship with markers of inflammation and bone metabolism.
- Conditions
- Vitamin D, Prematurity
- Being tested
- Vitamin D3, vitamin D3 placebo
- Keywords
- vitamin d, prematurity, 25(OH)D, infant, CRP, PTH
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called DVi-Sol
400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
vitamin D3 placeboDietary supplement
Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | This group will recieve the current standard of care for infants in the NICU, recieving infant formula that provides less than 400 IU of vitamin D a day. Receives: Dietary Supplement: vitamin D3 placebo |
| Vitamin D | Experimental | This group will recieve standard of care infant formulas that provide less than 400 IU of vitamin D a day, in addition they will be supplemented with 400 IU of vitamin D3 daily. Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25-Hydroxyvitamin D [25(OH)D] Levels
Total serum 25(OH)D level is currently considered the best indicator of vitamin D supply to the body from cutaneous synthesis and nutritional intake. For infants, ≤37.5 nmol/L (15 ng/mL) would be considered indicative of deficiency and >50 nmol/L (20 ng/mL) as indicative of vitamin D sufficiency.
Measured: 30 days
Secondary outcomes (2)
Serum C-reactive protein (CRP)
Serum C-reactive protein (CRP) is a protein made by the liver and increases when there's inflammation in the body. The upper normal reference levels range from 6 to 20 mg/L as cutoff levels to indicate the presence of sepsis or infection.
Measured: 30 days
Serum intact parathyroid hormone (iPTH)
Secretion of parathyroid hormone (PTH) is regulated by the level of calcium in the blood. Low serum calcium causes increased PTH to be secreted, whereas increased serum calcium inhibits PTH release. Normal values are 10 to 55 picograms per milliliter (pg/mL).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study start7 Aug 2009
- Primary completion1 Aug 2010
- Study completion1 Aug 2010
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 Vitamin DStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Creighton University Medical Center
- Responsible party
- Sponsor
- Investigators
- Corrine Hanson, PhD, RD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042561
- Sponsor's protocol ID
- 0281-09-FB
- Status last verified
- Aug 2023
- First submitted
- 31 Dec 2009
- Last updated
- 1 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Status and Dose Response in Infants
- ClinicalTrials.gov ID
- NCT01042561
- Acronym / sponsor ID
- 0281-09-FB
- Conditions
- Vitamin D, Prematurity
- Keywords
- vitamin d, prematurity, 25(OH)D, infant, CRP, PTH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Creighton University Medical Center
- Study start
- 7 Aug 2009 (actual)
- Primary completion
- 1 Aug 2010 (actual)
- Study completion
- 1 Aug 2010 (actual)
- First posted
- 5 Jan 2010 (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 examine the relationship of serum 25(OH)D levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism.
Detailed description
It is hypothesized that serum 25(OH)D levels in infants 32 weeks and greater gestation are not maintained at optimal levels of greater than 32 ng/Ml with currently available infant formulas, and that this will have an inverse relationship with markers of inflammation and bone metabolism.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: vitamin D3 placeboThis group will recieve the current standard of care for infants in the NICU, recieving infant formula that provides less than 400 IU of vitamin D a day. |
| Vitamin D | Experimental | Dietary Supplement: Vitamin D3This group will recieve standard of care infant formulas that provide less than 400 IU of vitamin D a day, in addition they will be supplemented with 400 IU of vitamin D3 daily. |
Who may qualify
- Ages
- 5 minutes to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- greater than 32 weeks gestation,
- exclusively formula fed.
Key exclusion criteria (11 listed)
- less than 32 weeks gestation,
- less than 1500 grams,
- recieving maternal breast milk,
- recieving parenteral nutrition,
- congenital anomolies,
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 |
|---|---|---|
| Vitamin D3Also: DVi-Sol400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days. | Dietary supplement | Vitamin D |
| vitamin D3 placeboPlacebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days. | Dietary supplement | placebo |
Primary outcome
Serum 25-Hydroxyvitamin D [25(OH)D] Levels
Time frame: 30 days
Total serum 25(OH)D level is currently considered the best indicator of vitamin D supply to the body from cutaneous synthesis and nutritional intake. For infants, ≤37.5 nmol/L (15 ng/mL) would be considered indicative of deficiency and >50 nmol/L (20 ng/mL) as indicative of vitamin D sufficiency.
2 secondary outcomes
Serum C-reactive protein (CRP)
Time frame: 30 days
Serum intact parathyroid hormone (iPTH)
Time frame: 30 days
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 1 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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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 Hanson, PhD, RD 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 Vitamin D3 in people with Vitamin D and Prematurity, 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 11 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 1 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. Some participants in this study may receive a placebo. 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-Hydroxyvitamin D [25(OH)D] Levels (time frame: 30 days). 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 NCT01042561, 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 1 Sep 2023.