NCT01601847

Brief Summary

The goal of this study is to identify a vitamin D supplementation strategy that best promotes the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational age). This is a high risk population that seems to have unique vitamin D needs, and inappropriate supplementation may promote wheezing or allergy. The results of this study will help form nutritional recommendations for the approximately 100,000 black infants born at 30-36 weeks gestational age in the U.S. every year.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 8, 2018

Completed
Last Updated

June 8, 2018

Status Verified

May 1, 2018

Enrollment Period

4.2 years

First QC Date

May 16, 2012

Results QC Date

March 11, 2018

Last Update Submit

May 8, 2018

Conditions

WheezingAllergy

Outcome Measures

Primary Outcomes (1)

  • Number of Infants With Recurrent Wheezing

    Recurrent wheezing was defined as more than 1 episode of wheezing reported during the study period. Separate episodes were defined as occurring at least 2 weeks apart.

    up to 12 months adjusted age

Secondary Outcomes (2)

  • Number With Infants With Allergic Sensitization as Measured by the PhadiaTop Infant Assay

    Measured at the 12 month adjusted age visit

  • Bone Density

    Measured at the 12 month adjusted age visit

Study Arms (2)

Sustained

ACTIVE COMPARATOR

Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake

Drug: Cholecalciferol

Diet-Limited

PLACEBO COMPARATOR

Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day

Dietary Supplement: Cholecalciferol

Interventions

CholecalciferolDIETARY_SUPPLEMENT

Once the dietary intake of vitamin D has exceeded 200 IU/Day, the infants will receive placebo until they are 6 months of age adjusted for prematurity

Diet-Limited

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • /7-36 6/7 weeks gestational age (GA) at birth;
  • family identifies the child as black or African American;
  • \< 28 days of supplemental oxygen (subsequent oxygen therapy for \< 72 hrs for a brief subsequent illness or surgery will be allowed);
  • admitted to a participating site NICU, special care nursery, transitional care nursery, or well-baby nursery as a neonate; and
  • \< 40 weeks corrected GA at enrollment.

You may not qualify if:

  • BPD (\> 28 days of supplemental oxygen);
  • pre-existing diagnosis of moderate to severe osteopenia of prematurity and/or alkaline phosphatase \> 700;
  • history of fracture;
  • gastrointestinal surgery, including for NEC;
  • known gastrointestinal malabsorption;
  • major congenital anomaly;
  • congenital pulmonary or airway disorder (e.g., cystic fibrosis, tracheomalacia, swallowing disorder, bronchopulmonary sequestration);
  • documented wheezing or stridor prior to enrollment;
  • previous vit. D supplementation with \> 400 IU/day;
  • family plans to move more than 60 miles from CWRU or other pre-defined radius at other sites;
  • baseline hypo- or hypercalcemia, hypo- or hyperphosphatemia; and
  • baseline 25(OH) D level \< 10 ng/ml.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Montefiore Medical Center

New York, New York, 10467, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44023, United States

Location

University Hospitals

Cleveland, Ohio, 44023, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (4)

  • Benson AC, Chen Z, Minich NM, Tatsuoka C, Furman L, Ross K, Hibbs AM. Human milk feeding and wheeze in Black infants born preterm. J Perinatol. 2022 Nov;42(11):1480-1484. doi: 10.1038/s41372-022-01471-w. Epub 2022 Aug 4.

    PMID: 35927485DERIVED

  • 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.

    PMID: 33305842DERIVED

  • Ledingham L, Tatsuoka C, Minich N, Ross KR, Kerns LA, Wagner CL, Fuloria M, Groh-Wargo S, Zimmerman T, Hibbs AM. Burden of prematurity-associated recurrent wheezing: caregiver missed work in the D-Wheeze trial. J Perinatol. 2021 Jan;41(1):69-76. doi: 10.1038/s41372-020-0729-7. Epub 2020 Jul 21.

    PMID: 32694857DERIVED

  • Hibbs AM, Ross K, Kerns LA, Wagner C, Fuloria M, Groh-Wargo S, Zimmerman T, Minich N, Tatsuoka C. Effect of Vitamin D Supplementation on Recurrent Wheezing in Black Infants Who Were Born Preterm: The D-Wheeze Randomized Clinical Trial. JAMA. 2018 May 22;319(20):2086-2094. doi: 10.1001/jama.2018.5729.

    PMID: 29800180DERIVED

MeSH Terms

Conditions

Respiratory SoundsHypersensitivity

Interventions

CholecalciferolErgocalciferolsVitamin D

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Dr. Anna Maria Hibbs
Organization
Case Western Reserve University
annamaria.hibbs@cwru.edu
216-844-3387

Study Officials

  • Anna Maria Hibbs, MD, MSCE

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 18, 2012

Study Start

January 1, 2013

Primary Completion

March 12, 2017

Study Completion

March 12, 2017

Last Updated

June 8, 2018

Results First Posted

June 8, 2018

Record last verified: 2018-05

Locations

US(5)