Infant, Very Low Birth WeightNCT01363167
Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
A study testing 400 IU Cholecalciferol- Vitamin D Daily in people with Infant, Very Low Birth Weight and Calcium Deficiency, run by Medical University of South Carolina at 2 sites in United States.
Trial summary
This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Infant, Very Low Birth Weight, Calcium Deficiency, Vitamin D Deficiency
- What is being tested?
- 400 IU Cholecalciferol- Vitamin D Daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Oct 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 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any infant born at the Medical University of South Carolina <34 weeks gestation
- Less that 1500g at birth
- AGA
- Must be African American or Caucasian
- Each infant born of twin and triplet pregnancies will be eligible
Who cannot join
- Infants with major congenital anomalies or with hemolytic disease requiring exchange transfusion
- Infants born small for-gestational-age (SGA) or large for-gestational-age (LGA)
- Maternal uncontrolled thyroid disease
- Maternal Parathyroid disease
- Infants of races other than African American or Caucasian
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425-8750
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Identifying Vit D Deficiency in VLBW Infants Part 2
This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.
- Being tested
- 400 IU Cholecalciferol- Vitamin D Daily
- Keywords
- vitamin D, preterm infants, calcium, bone, parathyroid hormone
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 IU Cholecalciferol- Vitamin D DailyDietary supplement
Infants who are defined as vitamin D deficient at birth will be randomized to receive either 400 IU vitamin D/day or placebo daily until term age is reached.
| Study group | Role | What they receive |
|---|---|---|
| 400 IU Cholecalciferol - Vitamin D | Active comparator | Not described Receives: Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily |
| Placebo | Placebo comparator | Placebo contains Fractionated Coconut Oil Receives: Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Calcium Absorption
Measured: When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth
Parathyroid hormone concentration
Measured: At term age (expected 2-4 months)
Serum 25 hydroxyvitamin D status
Measured: At term age (expected 2-4 months)
Bone Health
Bone ultrasound measurement, serum alkaline phosphatase, and bone-specific alkaline phosphatase at birth and monthly until term age. Bone mineralization by DEXA scan at hospital discharge and term age.
Measured: At term age (expected 2-4 months)
Serum inflammatory cytokine concentrations
Measured: At birth (day 1)
Secondary outcomes (3)
Phosphorus Homeostasis
Measurement of serum and urine phosphorus concentrations
Measured: At term age (expected 2-4 months)
Growth parameters
Measured: At term age (expected 2-4 months)
Vitamin D Dose Safety as Measured by Urinary Calcium Excretion
Measured: At term age (expected 2-4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Very Low Birth WeightStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Sarah N Taylor, Medical University of South Carolina
- Investigators
- Sarah N. Taylor, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363167
- Sponsor's protocol ID
- HR# 17217
- Other IDs
- K23RR021891
- Status last verified
- Nov 2014
- First submitted
- 18 Apr 2011
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Vit D Deficiency in VLBW Infants Part 2
- ClinicalTrials.gov ID
- NCT01363167
- Acronym / sponsor ID
- HR# 17217
- Keywords
- vitamin D, preterm infants, calcium, bone, parathyroid hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 1 Jun 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 is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 IU Cholecalciferol - Vitamin D | Active comparator | Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily |
| Placebo | Placebo comparator | Dietary Supplement: 400 IU Cholecalciferol- Vitamin D DailyPlacebo contains Fractionated Coconut Oil |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Any infant born at the Medical University of South Carolina <34 weeks gestation
- Less that 1500g at birth
- AGA
- Must be African American or Caucasian
- Each infant born of twin and triplet pregnancies will be eligible
Key exclusion criteria (5 listed)
- Infants with major congenital anomalies or with hemolytic disease requiring exchange transfusion
- Infants born small for-gestational-age (SGA) or large for-gestational-age (LGA)
- Maternal uncontrolled thyroid disease
- Maternal Parathyroid disease
- Infants of races other than African American or Caucasian
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 |
|---|---|---|
| 400 IU Cholecalciferol- Vitamin D DailyInfants who are defined as vitamin D deficient at birth will be randomized to receive either 400 IU vitamin D/day or placebo daily until term age is reached. | Dietary supplement | 400 IU Cholecalciferol - Vitamin D, Placebo |
Primary outcome
Intestinal Calcium Absorption
Time frame: When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth
Parathyroid hormone concentration
Time frame: At term age (expected 2-4 months)
Serum 25 hydroxyvitamin D status
Time frame: At term age (expected 2-4 months)
Bone Health
Time frame: At term age (expected 2-4 months)
Bone ultrasound measurement, serum alkaline phosphatase, and bone-specific alkaline phosphatase at birth and monthly until term age. Bone mineralization by DEXA scan at hospital discharge and term age.
Serum inflammatory cytokine concentrations
Time frame: At birth (day 1)
3 secondary outcomes
Phosphorus Homeostasis
Time frame: At term age (expected 2-4 months)
Growth parameters
Time frame: At term age (expected 2-4 months)
Vitamin D Dose Safety as Measured by Urinary Calcium Excretion
Time frame: At term age (expected 2-4 months)
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 24 Nov 2014.
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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.
Sarah N. Taylor, M.D. principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 400 IU Cholecalciferol- Vitamin D Daily in people with Infant, Very Low Birth Weight and Calcium Deficiency, run by Medical University of South Carolina at 2 sites 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 5 inclusion and 5 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 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Intestinal Calcium Absorption (time frame: When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2014.