High Dose Vitamin D for Sickle Cell Disease

NCT01331148 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB00014694SCD Vitamin D
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D deficiency (VDD) is very common among African American adolescents and adults in the US, ten times higher than is seen in Caucasians. VDD is also quite common in sickle cell disease (SCD). Both VDD and SCD can cause chronic pain, compression fractures, and muscle weakness. The investigators believe VDD may contribute to poor musculoskeletal health and chronic pain seen in pediatric SCD. In this study, the investigators aim to show that children and adolescents with SCD and chronic pain have lower levels of vitamin D compared to those without chronic pain. The investigators also aim to determine the clinical characteristics in SCD patients related to their vitamin D status. About 60 subjects (7 to 21 years old) will be enrolled on this study, 30 with chronic pain and 30 without chronic pain. The investigators will assess baseline characteristics including vitamin D levels, bone turnover rates (measured by C telopeptide blood levels \[CTx\]), markers of inflammation and oxidative stress levels in blood, baseline hemoglobin and other laboratory parameters, presence of abnormal bones on chest x-ray, pulmonary function, opioid analgesic use, overall muscle strength, quality of life and depression. To evaluate the impact of vitamin D replacement on these baseline characteristics, the investigators will randomize subjects to receive either placebo or high dose vitamin D for 6 weeks after which time the investigators will evaluate overall vitamin D status, muscle and bone health, depression, quality of life, pain status and use of opioid pain medications, inflammation and oxidative status comparing before and after treatment with high dose vitamin D. The investigators will give-at no cost to subjects-a daily supplement that will provide the recommended daily allowance of calcium and vitamin D that contains 500mg Calcium and 200IU vitamin D to subjects throughout the study period. Subjects will be in the study for 7 months and have five to six study visits.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; vitamin D; pediatrics; pain

Outcome Measures

Primary Outcomes (1)

• 25 (OH)D in Nmol/L Between Baseline and 6 Months

  Change in 25 (OH)D level in SCD patients with and without chronic pain between baseline and 6 months.

  Baseline and after 6 months of study participation

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

10,000 IU per caplet, with vitamin D dose based on weight, ranging from 240,000 IU to 600,000 IU. Patients will receive calcium/vitamin D daily soft chew as well.

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

placebo only, all patients will receive calcium/vitamin D chew

Other: Placebo

Interventions

Vitamin D DRUG

10,000 IU/caplet, patients receiving 240,000 IU to 600,000 IU cumulative Vitamin D dose based on weight.

Also known as: cholecalciferol

Vitamin D

Placebo OTHER

placebo with daily calcium/Vitamin D soft chews

Placebo

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all sickle cell genotypes including SS, SB0thal, SC, SB+Thal
• Age 7-21 years old
• Last PRBC transfusion \>30 days prior

You may not qualify if:

• chronic renal failure
• chronic liver disease
• recent hospitalization \<14 days
• history of malignancy
• serum calcium level as defined in protocol section D 2.2
• treatment with concommitant medications as defined in section D 2.2 of the protocol
• known malabsorption or short gut syndrome or conditions associated with poor GI absorption
• patients currently on high dose vitamin D therapy

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Children's Healthcare of Atlanta: collaborator
• Emory University: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Osunkwo I, Ziegler TR, Alvarez J, McCracken C, Cherry K, Osunkwo CE, Ofori-Acquah SF, Ghosh S, Ogunbobode A, Rhodes J, Eckman JR, Dampier C, Tangpricha V. High dose vitamin D therapy for chronic pain in children and adolescents with sickle cell disease: results of a randomized double blind pilot study. Br J Haematol. 2012 Oct;159(2):211-5. doi: 10.1111/bjh.12019. Epub 2012 Aug 28.

  PMID: 22924607 RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Interventions

Vitamin D; Cholecalciferol

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Short follow up period small number of patients High drop out rate from adherence to diary completion

Results Point of Contact

• Title: Ifeyinwa Osunkwo, MD, MPH, Principal Investigator
• Organization: Carolinas Healthcare System

ify.osunkwo@carolinashealthcare.org

980 442 5001

Study Officials

• Ifeyinwa Osunkwo, MD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• 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: SPONSOR

Model Details: randomized placebo controlled double blind

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 7, 2011
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2013
• Last Updated: August 9, 2022
• Results First Posted: August 9, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 12 months from study completion

Locations

US (1)