Study of Vitamin D in Children With Sickle Cell Disease

NCT01276587 | Completed Phase 1 Results DMC

• 1 other identifier: AAAF2598
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to answer the question whether monthly oral vitamin D3 supplementation, 100,000 IU, will be safe and effective in raising serum 25-hydroxyvitamin D (form of vitamin D measured in the blood) to levels considered sufficient (30 ng/mL) but well below the threshold for toxicity (150 ng/mL) in children with sickle cell disease. Information from this study will be crucial before we perform a larger clinical trial to determine the effects of vitamin D in reducing respiratory complications in patients with sickle cell disease.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; children; vitamin D; safety

Outcome Measures

Primary Outcomes (1)

• Serum 25-hydroxyvitamin D Concentration

  Serum 25-hydroxyvitamin D level was measured at 6 months.

  Up to 6 months

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

Oral vitamin D3 100,000 IU administered monthly for six months in children and adolescents with sickle cell disease

Also known as: Vitamin D

Single arm

Eligibility Criteria

• Age: 3 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients with sickle cell disease
• to 20 years old
• pregnant females with sickle cell disease are eligible

You may not qualify if:

• no informed consent or assent
• unable or unwilling to comply with requirements of the clinical trial
• participation in another clinical trial
• history of hypercalcemia or diagnosis of any medical condition associated with hypercalcemia, such as primary hyperparathyroidism, malignancy, familial hypocalciuric hypercalcemia, William's syndrome and other rare causes
• therapy with thiazide diuretics or lithium carbonate
• known renal or liver disease
• known malabsorption syndrome and inflammatory bowel disease
• chronic use of corticosteroids, excluding inhaled steroids
• current use of anticonvulsants (phenytoin, phenobarbital, carbamazepine)
• current intake of vitamin D and calcium supplements
• initiation of hydroxyurea or iron chelation therapy within the past 3 months
• serum 25hydroxyvitamin D \>60 ng/mL

Sponsors & Collaborators

• Gary M Brittenham, MD: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Margaret Lee, MD
• Organization: Columbia University

ml653@cumc.columbia.edu

212-305-6290

Study Officials

• Margaret T Lee, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: James A. Wolff Professor of Pediatrics

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 13, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 12, 2023
• Results First Posted: April 12, 2023

Record last verified: 2018-03

Locations

US (1)