Daily Vitamin D for Sickle-cell Respiratory Complications

Summary

This study aims to answer the question whether daily oral vitamin D supplementation can reduce the risk of respiratory or lung complications in children and adolescents with sickle cell disease. Respiratory problems are the leading causes of sickness and of death in sickle cell disease. The investigators hypothesize that daily oral vitamin D3, compared to monthly oral vitamin D, will rapidly increase circulating vitamin D3, and reduce the rate of respiratory complications by 50% or more within the first year of supplementation in children and adolescents with sickle cell disease.

This study is funded by the FDA Office of Orphan Products Development (OOPD).

Conditions

• Sickle Cell Disease
• Anemia, Sickle Cell
• Anemia, Hemolytic, Congenital
• Respiratory Tract Diseases
• Respiration Disorders
• Acute Chest Syndrome
• Lung Diseases
• Asthma
• Respiratory Tract Infections
• Nutrition Disorders
• Deficiency Diseases Vitamin
• Vitamin D Deficiency

Interventions

DRUG

Daily oral vitamin D3, 3,333 IU

Oral vitamin D3, 3,333 IU, will be administered daily.

DRUG

Monthly oral vitamin D3, 100,000 IU

Oral vitamin D3, 100,000 IU, will be administered monthly.

DRUG

Placebo oral tablet

Participants randomized to receive once monthly oral bolus of vitamin D3, will receive placebo on all other days of the month.

Sponsors & Collaborators

• FDA Office of Orphan Products Development

  collaborator FED

• Columbia University

  lead OTHER

Principal Investigators

• Gary M Brittenham, MD · Columbia University

• Margaret T Lee, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-15

Primary Completion

2024-06-18

Completion

2024-06-18

FDA Drug

Yes

Countries

• United States

Study Locations