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Vitamin D Supplementation in Children With Sickle Cell Disease

NCT04662476 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 662

Last updated 2021-04-13

No results posted yet for this study

Summary

Children aged 6 months to 12 years of age will be randomised to receive vitamin D 60,000IU once a month for 3 months or a placebo. The vitamin D will be in form of granules supplied in sachets. The primary study outcomes will be incidence of hospitalisation and change in vitamin D levels following supplementation. Secondary outcomes will include incidence of vaso-occlusive crisis (VOC), acute severe respiratory illness, Vitamin D related Severe adverse events and requirements for blood transfusion

Conditions

  • Children With Sickle Cell Disease at Mulago Hospital

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 supplement

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Principal Investigators

  • Grace Ndeezi, PhD · Makerere University, Kampala, Uganda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2021-12-31
Completion
2022-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662476 on ClinicalTrials.gov