Status:

UNKNOWN

Vitamin D Supplementation in Children With Sickle Cell Disease

Lead Sponsor:

Makerere University

Conditions:

Children With Sickle Cell Disease at Mulago Hospital

Eligibility:

All Genders

6-12 years

Phase:

NA

Brief 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 pr...

Detailed Description

BACKGROUND: More than 75% of all children with sickle cell anemia (SCA) are born in sub-Saharan Africa annually. The hallmark of SCA is haemolytic anaemia and or pain crisis that often require hospita...

Eligibility Criteria

Inclusion

  • Documented sickle cell disease (HbSS supported by hemoglobin electrophoresis results) attending Mulago Hospital Sickle Cell Clinic)
  • Age range of 6 months to 12 years, inclusive, at the time of enrolment
  • Weight at least 5.0 kg at the time of enrolment
  • Willingness to comply with all study-related treatments, evaluations, and follow-up

Exclusion

  • Known other chronic medical condition (e.g., HIV, malignancy, Renal \& liver disease, active clinical tuberculosis)
  • Severe acute malnutrition determined by impaired growth parameters as defined by WHO weight for length/height less than -3SD.
  • Evidence of Vitamin D supplementation in the past one month (by prescription or drug sample)

Key Trial Info

Start Date :

May 17 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 31 2022

Estimated Enrollment :

662 Patients enrolled

Trial Details

Trial ID

NCT04662476

Start Date

May 17 2021

End Date

January 31 2022

Last Update

April 13 2021

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