Effect of Vitamin D Supplementation on Sickle Cell Disease Hospitalisation and Related Complications Among Children in Mulago Hospital: A Randomised Clinical Trial

Study point of contact

Ruth Namazzi, MMED
+256 772356331
[email protected]
Grace Ndeezi, PhD
+256 772453191
[email protected]

Age

6 to 12 Years

Genotypes

HbSS

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Dietary Supplement

Compensation

Unknown

About the study

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

participation requirements

1. Documented sickle cell disease (HbSS supported by hemoglobin electrophoresis results)
attending Mulago Hospital Sickle Cell Clinic)

2. Age range of 6 months to 12 years, inclusive, at the time of enrolment

3. Weight at least 5.0 kg at the time of enrolment

4. Willingness to comply with all study-related treatments, evaluations, and follow-up

participation restrictions

1. Known other chronic medical condition (e.g., HIV, malignancy, Renal & liver disease,
active clinical tuberculosis)

2. Severe acute malnutrition determined by impaired growth parameters as defined by WHO
weight for length/height less than -3SD.

3. Evidence of Vitamin D supplementation in the past one month (by prescription or drug
sample)