Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level

NCT01838447 | Completed Phase 2 Results DMC

• 1 other identifier: VITAMINDINCHD-01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Our research group has shown that almost all children with congenital heart disease (CHD) are vitamin D deficient following heart surgery. This work strongly suggests that the vitamin D intake presently recommended for healthy children, and also given to children with CHD, is inadequate to prevent vitamin D deficiency following surgery. Unfortunately, there have been no studies investigating any other vitamin D dose in children with heart disease. Recently, a higher dose of vitamin D intake has been approved (by the Institute of Medicine and Health Canada) and recent work on healthy children has shown it to be safe. The objective of this study is to determine whether this recently approved higher dose of vitamin D can safely reduce the number of children who are vitamin D deficient following surgery. This dose evaluation study will also evaluate whether it is possible to perform a large study (across Canada) to determine whether vitamin D supplementation can improve outcomes following surgery. It is hypothesized that a daily high dose vitamin D regimen, modeled on the Institute of Medicine daily upper tolerable intake level (UL), will significantly reduce vitamin D deficiency following CHD surgery, when compared with usual intake.

Conditions

Vitamin D Deficiency; Thoracic Surgery; Pediatric Disorders; Heart Defects, Congenital

Keywords

Vitamin D; Congenital Heart Disease; Cardiac Surgery; Pediatrics; Phase II Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Blood 25 Hydroxyvitamin D (25OHD) Concentrations

  Blood 25OHD will be measured to determine vitamin D deficiency, with a concentration below 50 nmol/L used to define deficiency. A PICU admission blood sample could not be obtained for one patient in the Usual Care Group and one patient in the High Dose Group, thus the total number analyzed differs from the full sample size.

  1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery)

Secondary Outcomes (6)

• Number of Participants With Hypercalcemia as a Vitamin D Related Adverse Event

  Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10

• Number of Participants With Hypercalciuria

  Immediately before surgery, on admission to the PICU following CHD surgery, and on the first post-operative day

• Vitamin D Parathyroid Renal Axis Function Through Changes in Blood 1,25-dihydroxycholecalciferol

  Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10

• Changes in Cathelicidin as Measure of Innate Immune Function

  Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10

• Post-operative PICU Catecholamine Requirements

  At any point between PICU admission and discharge, an average length of 5-7 days and not longer than 60 days

Study Arms (2)

Usual care group

NO INTERVENTION

This group will receive daily cholecalciferol (vitamin D3) based on the Adequate Intake (AI) for infants and the Recommended Dietary Allowance (RDA) for children over 1 year. Specific dose amounts are 400 IU per day for infants (0-1 year), and 600 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a placebo solution.

High Dose Group

EXPERIMENTAL

This group will receive cholecalciferol (vitamin D3) based on the age-specific tolerable daily upper intake level (UL). Specific dose amounts are 1600 IU per day for infants (0-1 year), and 2400 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a dose of 1200 IU per day to account for vitamin D in formula.

Dietary Supplement: Cholecalciferol

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)

Also known as: Vitamin D3

High Dose Group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn (corrected gestational age between 36 weeks) up to 18 years
• Has CHD that will require surgery within the next 12 months
• CHD requiring surgical intervention with cardiopulmonary bypass

You may not qualify if:

• Born at less than 32 weeks gestational age
• Corrected gestational age of less than 36 weeks
• Cardiac or gastrointestinal disease preventing enteral feeds or drug administration prior to surgery
• Patient has confirmed or suspected Williams syndrome
• Proposed surgery to take place at another centre (outside of CHEO)

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• The Ottawa Hospital: collaborator
• McGill University: collaborator
• Children's University Hospital, Ireland: collaborator
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (65)

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  PMID: 33305842 DERIVED

• McNally JD, O'Hearn K, Fergusson DA, Lougheed J, Doherty DR, Maharajh G, Weiler H, Jones G, Khamessan A, Redpath S, Geier P, McIntyre L, Lawson ML, Girolamo T, Menon K; Canadian Critical Care Trials Group. Prevention of post-cardiac surgery vitamin D deficiency in children with congenital heart disease: a pilot feasibility dose evaluation randomized controlled trial. Pilot Feasibility Stud. 2020 Oct 22;6:159. doi: 10.1186/s40814-020-00700-3. eCollection 2020.

  PMID: 33110622 DERIVED

• McNally JD, O'Hearn K, Lawson ML, Maharajh G, Geier P, Weiler H, Redpath S, McIntyre L, Fergusson D, Menon K; Canadian Critical Care Trials Groups. Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial. Trials. 2015 Sep 9;16:402. doi: 10.1186/s13063-015-0922-8.

  PMID: 26353829 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Heart Defects, Congenital

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Katie O'Hearn, PICU Research Coordinator
• Organization: Children's Hospital of Eastern Ontario

kohearn@cheo.on.ca

613-737-7600

Study Officials

• James D McNally, M.D., Ph.D.

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

• Kusum Menon, M.D.

  Children's Hospital of Eastern Ontario

  STUDY CHAIR

• Lauralyn McIntyre, M.D.

  Ottawa Hospital

  STUDY CHAIR

• Dermot R Doherty, M.B., B.Ch.

  Temple Street Children's University Hospital Dublin and University College

  STUDY CHAIR

• Dean Ferguson, Ph.D.

  Ottawa Hospital Research Institute

  STUDY CHAIR

• Hope Weiler, Ph.D.

  McGill University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: Dr. James Dayre McNally, Pediatric Intensivist, Department of Pediatrics, CHEO, Associate Investigator, CHEO Research Institute

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 24, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 22, 2019
• Results First Posted: July 22, 2019

Record last verified: 2019-05

Locations

CA (1)