Back to resultsVitamin D Status and Dose Response in Infants
Primary Purpose
Vitamin D, Prematurity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
vitamin D3 placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitamin D focused on measuring vitamin d, prematurity, 25(OH)D, infant, CRP, PTH
Eligibility Criteria
Inclusion Criteria:
- greater than 32 weeks gestation,
- exclusively formula fed.
Exclusion Criteria:
- less than 32 weeks gestation,
- less than 1500 grams,
- recieving maternal breast milk,
- recieving parenteral nutrition,
- congenital anomolies,
- disorders of vitamin D metabolism,
- inborn errors of metabolism,
- seizure disorders,
- parathroid disease,
- liver, GI tract, or kidney disease, and
- disorders of calcium metabolism.
Sites / Locations
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
Vitamin D
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT01042561
First Posted
December 31, 2009
Last Updated
August 29, 2023
Sponsor
University of Nebraska
Collaborators
Creighton University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01042561
Brief Title
Vitamin D Status and Dose Response in Infants
Official Title
Vitamin D Status and Dose Response in Infants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 7, 2009 (Actual)
Primary Completion Date
August 1, 2010 (Actual)
Study Completion Date
August 1, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Creighton University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D, Prematurity
Keywords
vitamin d, prematurity, 25(OH)D, infant, CRP, PTH
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
DVi-Sol
Intervention Description
400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3 placebo
Intervention Description
Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
Primary Outcome Measure Information:
Title
Serum 25-Hydroxyvitamin D [25(OH)D] Levels
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Serum C-reactive protein (CRP)
Description
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.
Time Frame
30 days
Title
Serum intact parathyroid hormone (iPTH)
Description
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).
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Minutes
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
greater than 32 weeks gestation,
exclusively formula fed.
Exclusion Criteria:
less than 32 weeks gestation,
less than 1500 grams,
recieving maternal breast milk,
recieving parenteral nutrition,
congenital anomolies,
disorders of vitamin D metabolism,
inborn errors of metabolism,
seizure disorders,
parathroid disease,
liver, GI tract, or kidney disease, and
disorders of calcium metabolism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrine Hanson, PhD, RD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33305842
Citation
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.
Results Reference
derived
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Vitamin D Status and Dose Response in Infants
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