- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01793402
Vitamin D Status and the Adequacy of Vitamin D Intake in Early Preterm Infants
April 17, 2013 updated by: Dr. Henry Akinbi, Children's Hospital Medical Center, Cincinnati
Adequacy of Vitamin D Intake and Vitamin D Status in Early Preterm Infants
Vitamin D is an essential nutrient.
Deficiency of vitamin D is widespread.
The prevalence of vitamin D deficiency in early preterm infants is unknown.
The American Academy of Pediatrics recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D. This study assesses vitamin D status at birth and during hospital stay in infants delivered delivered at earlier than or at 32 weeks gestation.
We also assess the adequacy of intake relative to the target set by the American Academy of Pediatrics for children.
Study Overview
Status
Completed
Conditions
Detailed Description
Vitamin D is important for bone health.
Deficiency of vitamin D is widespread and is associated with a variety of diseases.
Preterm infants are susceptible osteopenia of prematurity (OP).
Vitamin D deficiency may contribute to OP.
The American Academy of Pediatrics (AAP) recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D. Whether this level of intake or target serum concentration are achieved in early preterm infants is unknown.
We hypothesize that because early preterm infants are sequestered in the Newborn Intensive Care Units for an extended period of time, they will be deficient in vitamin D and that the current nutritional intake may not be adequate in meeting the AAP recommendation.
We assessed the concentration of serum 25-hydroxyvitamin-D in parturient mothers and in their newborns if they were less than 32 week gestation.
We monitored vitamin D intake during hospitalization in the Newborn Intensive Care Unit and serum 25-hydroxyvitamin-D at discharge.
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- University of Cincinnati Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 week (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All infants born at or less than 32 weeks postmenstrual age admitted to the Newborn Intensive Care Unit at University of Cincinnati Medical Center were eligible.
Intake of vitamin D and serum 25-hydroxyvitamin-D concentrations were assessed during stay in the Newborn Intensive Care Unit.
Description
Inclusion Criteria:
- All neonates delivered at or less than 32 weeks gestation were eligible.
Exclusion Criteria:
- Infants with lethal congenital malformation
- Infants that were not expected to survive to discharge
- Infants delivered from multiple gestation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Preterm infants born at or less than 32 weeks gestation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum 25-hydroxyvitamin-D concentration at the time of birth and at discharge from the hospital.
Time Frame: 6 weeks
|
This is a longitudinal study that assessed vitamin D status at birth in infants as well as in their mothers.
Daily intake of vitamin D was analyzed.
The serum concentration of 25-hydroxyvitamin-D at discharge was assessed.
We correlated maternal vitamin D with infants' vitamin D concentrations at birth.
We also correlated vitamin D concentration at birth with the concentration at discharge.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Henry T Akinbi, M.D., Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
February 13, 2013
First Submitted That Met QC Criteria
February 13, 2013
First Posted (Estimate)
February 15, 2013
Study Record Updates
Last Update Posted (Estimate)
April 19, 2013
Last Update Submitted That Met QC Criteria
April 17, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VitD_Preterm#1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypovitaminosis D
-
Hospices Civils de LyonCompleted
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Silvana De Giorgi; Davide Bizzoca; Angela NotarnicolaRecruitingHypovitaminosis DItaly
-
Madigan Army Medical CenterCompletedHypovitaminosis DUnited States
-
University of TromsoCompleted
-
Jewish General HospitalMcGill UniversityCompleted
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...Completed
-
Massachusetts General HospitalBio-Tech Pharmacal, Inc.CompletedHypovitaminosis DUnited States
-
Boston UniversityCompletedVitamin D Deficiency | Vitamin E Deficiency | Hypovitaminosis AUnited States
-
Harokopio UniversityUniversity College Cork; FrieslandCampinaCompletedHypovitaminosis D | Deficiency of MicronutrientsGreece
-
Chulalongkorn UniversityUnknownVitamin D2 Supplementation in Vitamin D InsufficiencyThailand