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Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy (D-Wheeze)

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ClinicalTrials.gov Identifier: NCT01601847
Recruitment Status : Completed
First Posted : May 18, 2012
Results First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Anna Maria Hibbs, Case Western Reserve University

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.

Condition or disease Intervention/treatment Phase
Wheezing Allergy Dietary Supplement: Cholecalciferol Drug: Cholecalciferol Phase 4

Detailed Description:
Black infants face the highest rates of prematurity in the U.S. (18%), have high rates of prematurity-associated wheezing illnesses, and tend to have lower vitamin D levels. The goal of this [comparative effectiveness] study is to identify a vit. D supplementation strategy that minimizes recurrent wheezing in infancy. Long recognized as important for bone health, a growing body of evidence suggests that vit. D may play a role in the regulation and development of many organ systems. The D pathway regulates lung inflammation and impacts morphogenesis, structure, and cell growth and survival in bronchial smooth muscle. Vit. D exposure has the potential to skew cytokine expression from a Th1 (less allergic) to a Th2 (more allergic) phenotype. Due to their developmental immaturity, preterm infants may be particularly vulnerable to any positive or negative effects of vit. D supplementation on the lung, airway, and immune system. Our preliminary data, supported by the literature, suggests that overly aggressive vit. D supplementation may inadvertently increase wheezing in infancy in black, but not white, preterm infants; however, vit. D deficiency could theoretically also increase wheezing via vulnerability to respiratory pathogens. The proposed study is a randomized clinical trial comparing the effect of two different enteral vitamin D supplementation strategies on recurrent wheezing in infancy in 300 black infants born preterm at 28 0/7-36 6/7 wks gestational age, a population for whom neither vit. D requirements nor optimal vit. D serum levels have been established. The investigators will test two strategies: (I) sustained supplementation until 6 mo. of age adjusted for prematurity, and (II) cessation of supplementation when a minimum dietary intake of 200 IU/day is reached. The specific aims are to characterize the effect of each strategy on (aim 1) recurrent wheezing and (aim 2) allergic sensitization and atopy. The investigators will (aim 3) explore the relationship between vit. D serum levels and recurrent wheezing. The investigators hypothesize that strategy II will be more effective in promoting pulmonary health by minimizing recurrent wheezing, allergic sensitization, and overall healthcare utilization, and will be sufficient to prevent clinical vit. D deficiency. The investigators also hypothesize that optimal vit. D serum levels will be lower than the norms for other populations.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy
Study Start Date : January 2013
Actual Primary Completion Date : March 12, 2017
Actual Study Completion Date : March 12, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sustained
Infants will remain on 400 IU/day of cholecalciferol until 6 months of age adjusted for prematurity, regardless of dietary intake
Drug: Cholecalciferol
Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity
Other Names:
  • D-Vi-Sol
  • Vitamin D

Placebo Comparator: Diet-Limited
Infants will receive placebo once their dietary intake of vitamin D has exceeded 200 IU/day
Dietary Supplement: Cholecalciferol
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




Primary Outcome Measures :
  1. Number of Infants With Recurrent Wheezing [ Time Frame: up to 12 months adjusted age ]
    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.


Secondary Outcome Measures :
  1. Number With Infants With Allergic Sensitization as Measured by the PhadiaTop Infant Assay [ Time Frame: Measured at the 12 month adjusted age visit ]
    Measured using the Phadiatop Infant IgE panel

  2. Bone Density [ Time Frame: Measured at the 12 month adjusted age visit ]
    Measured by bone speed of sound (ultrasound)



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. 28 0/7-36 6/7 weeks gestational age (GA) at birth;
  2. family identifies the child as black or African American;
  3. < 28 days of supplemental oxygen (subsequent oxygen therapy for < 72 hrs for a brief subsequent illness or surgery will be allowed);
  4. admitted to a participating site NICU, special care nursery, transitional care nursery, or well-baby nursery as a neonate; and
  5. < 40 weeks corrected GA at enrollment.

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601847


Locations
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United States, New York
Montefiore Medical Center
New York, New York, United States, 10467
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44023
University Hospitals
Cleveland, Ohio, United States, 44023
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Case Western Reserve University
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
Investigators
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Principal Investigator: Anna Maria Hibbs, MD, MSCE Case Western Reserve University
  Study Documents (Full-Text)

Documents provided by Anna Maria Hibbs, Case Western Reserve University:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anna Maria Hibbs, Assistant Professor of Pediatrics, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01601847     History of Changes
Other Study ID Numbers: R01HL109293 ( U.S. NIH Grant/Contract )
R01HL109293 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2012    Key Record Dates
Results First Posted: June 8, 2018
Last Update Posted: June 8, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents