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ViDES Trial (Vitamin D Extra Supplementation)

Primary Purpose

Vitamin D Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
800 IU/day vitamin D supplementation with feedings in the first 28 days after birth
Usual Care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vitamin D Deficiency focused on measuring Premature infant, Vitamin D

Eligibility Criteria

24 Hours - 96 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants born at < 28 weeks gestational age (GA) or <1000 grams birth weight (BW)
  • Inborn
  • Informed written consent in an Institutional Review Board (IRB)-approved manner

Exclusion Criteria:

  • GA >32 weeks regardless of birth weight (BW)
  • Any major congenital anomaly
  • An overt congenital nonbacterial infection
  • Prenatal diagnosis of disorders that affect vitamin D absorption (e.g, cystic fibrosis)
  • Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care plus placebo

Usual care plus vitamin D supplementation

Arm Description

Infants will receive placebo (normal saline) in the first 28 days after birth. Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.

Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day (when feedings reach about 120 -160 mL/kg/day). At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.

Outcomes

Primary Outcome Measures

25-hydroxyvitamin D (25[OH]D) level

Secondary Outcome Measures

25-hydroxyvitamin D (25[OH]D) level
Type of respiratory support required at 36 weeks postmenstrual age
Data will be reported categorically as: Number of participants who survive without respiratory support Number of participants who survive with nasal cannula at ≤ 2 liters (L)/minute Number of participants who survive with nasal cannula >2 L/minute or noninvasive positive airway pressure Number of participants who survive with invasive mechanical ventilation Number of participants who die
Length of Hospital stay
Number of participants who are still on respiratory support
Respiratory support includes supplemental oxygen and positive pressure ventilation.
Number of days of supplemental oxygen
Number of days of mechanical ventilation
Number of days of positive pressure support
Number of participants who receive steroid treatment to decrease respiratory support
Number of participants with pulmonary hypertension
Number of participants with wheezing
Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Number of participants with any fractures
Number of participants with hospital-acquired sepsis
Calcium level
Phosphorus level
Alkaline phosphatase level
Neurodevelopment as assessed by the Bayley-IV Scales of Infant and Toddler Development
Score ranges from 40 to 160, with a higher score indicating a better outcome.
Number of participants with neurodevelopmental impairment (NDI)
Number of participants who die or have a morbidity
Morbidities include retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), neurodevelopmental impairment (NDI), necrotizing enterocolitis (NEC), and patent ductus arteriosus (PDA).
Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by Liquid Chromatography with tandem mass spectrometry (LC-MS/MS)
Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by LC-MS/MS
Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS
Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS
Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS
Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS

Full Information

First Posted
July 11, 2022
Last Updated
July 13, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS), The Gerber Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05459298
Brief Title
ViDES Trial (Vitamin D Extra Supplementation)
Official Title
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS), The Gerber Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are <28 weeks gestational age (GA) or <1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Premature infant, Vitamin D

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care plus placebo
Arm Type
Active Comparator
Arm Description
Infants will receive placebo (normal saline) in the first 28 days after birth. Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.
Arm Title
Usual care plus vitamin D supplementation
Arm Type
Experimental
Arm Description
Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day (when feedings reach about 120 -160 mL/kg/day). At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
Placebo is normal saline, given in the first 28 days after birth, prepared to have the same volume and appearance as vitamin D, which is a clear odorless solution.
Intervention Type
Dietary Supplement
Intervention Name(s)
800 IU/day vitamin D supplementation with feedings in the first 28 days after birth
Other Intervention Name(s)
Cholecalciferol
Intervention Description
800 IU/day Vitamin D supplementation until 400 IU/day are provided as part of usual care (started when infants receive full feedings of about 120-160 mL/kg/day). At that point the intervention becomes a supplement of 400 IU/day above that given with usual care. In this way all infants in the intervention group receive 800 IU/day of vitamin D total supplementation in the first 28 days after birth with feedings.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.
Primary Outcome Measure Information:
Title
25-hydroxyvitamin D (25[OH]D) level
Time Frame
about 28 days after birth
Secondary Outcome Measure Information:
Title
25-hydroxyvitamin D (25[OH]D) level
Time Frame
36 weeks after birth
Title
Type of respiratory support required at 36 weeks postmenstrual age
Description
Data will be reported categorically as: Number of participants who survive without respiratory support Number of participants who survive with nasal cannula at ≤ 2 liters (L)/minute Number of participants who survive with nasal cannula >2 L/minute or noninvasive positive airway pressure Number of participants who survive with invasive mechanical ventilation Number of participants who die
Time Frame
36 weeks postmenstrual age (or at the time of discharge home if earlier)
Title
Length of Hospital stay
Time Frame
from time of birth to time of discharge (about 0 to 60 weeks after birth)
Title
Number of participants who are still on respiratory support
Description
Respiratory support includes supplemental oxygen and positive pressure ventilation.
Time Frame
22 to 26 months corrected age
Title
Number of days of supplemental oxygen
Time Frame
from time of birth to time of discharge (about 0 to 60 weeks after birth)
Title
Number of days of mechanical ventilation
Time Frame
from time of birth to time of discharge (about 0 to 60 weeks after birth)
Title
Number of days of positive pressure support
Time Frame
from time of birth to time of discharge (about 0 to 60 weeks after birth)
Title
Number of participants who receive steroid treatment to decrease respiratory support
Time Frame
from baseline to 36 weeks postmenstrual age
Title
Number of participants with pulmonary hypertension
Time Frame
36 weeks postmenstrual age
Title
Number of participants with wheezing
Time Frame
2 years
Title
Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Description
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Time Frame
28 days of life
Title
Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Description
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Time Frame
36 weeks postmenstrual age
Title
Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Description
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Time Frame
2 years
Title
Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Description
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Time Frame
28 days of life
Title
Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Description
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Time Frame
36 weeks postmenstrual age
Title
Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Description
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Time Frame
2 years
Title
Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Description
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Time Frame
28 days of life
Title
Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Description
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Time Frame
36 weeks postmenstrual age
Title
Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator
Description
Z-scores range from -4 standard deviations to +4 standard deviations. A higher Z-score indicates a better outcome.
Time Frame
2 years
Title
Number of participants with any fractures
Time Frame
from baseline to 36 weeks postmenstrual age
Title
Number of participants with hospital-acquired sepsis
Time Frame
from day 3 after birth to the time of discharge (which is 0 to 60 weeks after birth)
Title
Calcium level
Time Frame
0 to 36 weeks postmenstrual age
Title
Phosphorus level
Time Frame
0 to 36 weeks postmenstrual age
Title
Alkaline phosphatase level
Time Frame
0 to 36 weeks postmenstrual age
Title
Neurodevelopment as assessed by the Bayley-IV Scales of Infant and Toddler Development
Description
Score ranges from 40 to 160, with a higher score indicating a better outcome.
Time Frame
2 years
Title
Number of participants with neurodevelopmental impairment (NDI)
Time Frame
2 years
Title
Number of participants who die or have a morbidity
Description
Morbidities include retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), neurodevelopmental impairment (NDI), necrotizing enterocolitis (NEC), and patent ductus arteriosus (PDA).
Time Frame
36 weeks postmenstrual age
Title
Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by Liquid Chromatography with tandem mass spectrometry (LC-MS/MS)
Time Frame
about 28 days after birth
Title
Vitamin D status as indicated by serum concentration of 24,25(OH)2D3 as assessed by LC-MS/MS
Time Frame
36 weeks postmenstrual age
Title
Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS
Time Frame
about 28 days after birth
Title
Vitamin D status as indicated by serum concentration of 3-epi-25(OH)D3 as assessed by LC-MS/MS
Time Frame
36 weeks postmenstrual age
Title
Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS
Time Frame
about 28 days after birth
Title
Vitamin D status as indicated by serum concentration of 25(OH)D3 as assessed by LC-MS/MS
Time Frame
36 weeks postmenstrual age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
96 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants born at < 28 weeks gestational age (GA) or <1000 grams birth weight (BW) Inborn Informed written consent in an Institutional Review Board (IRB)-approved manner Exclusion Criteria: GA >32 weeks regardless of birth weight (BW) Any major congenital anomaly A known congenital nonbacterial infection Prenatal diagnosis of disorders that affect vitamin D absorption (e.g, cystic fibrosis) Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria del Mar Romero López, MD
Phone
713-500-7283
Email
Maria.del.Mar.RomeroLopez@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily K Stephens, BSN, RNC-NIC
Phone
(713) 500-5734
Email
Emily.K.Stephens@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria del Mar Romero López, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria del Mar Romero López, MD
Phone
713-500-7283
Email
Maria.del.Mar.RomeroLopez@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Emily Stephens, BSN, RNC-NIC
Phone
(713) 500-5734
Email
Emily.K.Stephens@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Matthew Rysavy, MD, PhD
First Name & Middle Initial & Last Name & Degree
Amir Khan, MD
First Name & Middle Initial & Last Name & Degree
Jon Tyson, MD, MPH
First Name & Middle Initial & Last Name & Degree
Claudia Pedroza, PhD
First Name & Middle Initial & Last Name & Degree
Mamta Naik, RD, PharmD, BCPPS

12. IPD Sharing Statement

Plan to Share IPD
No

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ViDES Trial (Vitamin D Extra Supplementation)

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