Vitamin D Supplementation in Children With Sickle Cell Disease

Children With Sickle Cell Disease at Mulago Hospital Clinical Trial

— VIDS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04662476
• Other study ID #: 2020-117
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2021
• Source: Makerere University
• Contact: Grace Ndeezi, PhD
• Phone: +256 772453191
• Email: gndeezi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 hospitalisation. Interventions to reduce the complications, which are prerequisites for frequent hospitalisations, are needed urgently. Vitamin D deficiency is common in children with SCA and is associated with recurrent vaso-occlusive crisis, blood transfusion, hospitalisation and infections. Routine vitamin D supplementation is not practiced in the care of sickle cell disease patients yet it has been associated with improved bone health and bone mineral density, reduced chronic pain and improved quality of life. HYPOTHESIS: Vitamin D supplementation will lead to a lower incidence of hospitalisation than placebo in Ugandan children with SCA. METHODS: The study will be a randomized, placebo-controlled, double blind clinical trial in which 331 Ugandan children with SCA aged 6 months to 12 years inclusive will receive vitamin D (60,000IU granules monthly) and another 331 a placebo (identical to vitaminD in appearance) for 3 months. The primary study outcome will be incidence of hospitalisation. 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 IMPACT: If this trial shows a reduction in hospitalisation, it will be the basis for a multi-site pre-post intervention clinical trial to assess real-world safety and efficacy of Vitamin D in African children with SCA. The monthly administration is easy, and since vitamin D is inexpensive, this trial has the potential to improve the health of hundreds/ thousands of African children with SCA through reduction of infection-related morbidity and mortality.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 662
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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)

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Children With Sickle Cell Disease at Mulago Hospital

Intervention

Dietary Supplement:
• Vitamin D3
Vitamin D3 supplement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

References & Publications (4)

Dougherty KA, Schall JI, Bertolaso C, Smith-Whitley K, Stallings VA. Vitamin D Supplementation Improves Health-Related Quality of Life and Physical Performance in Children with Sickle Cell Disease and in Healthy Children. J Pediatr Health Care. 2020 Sep - Oct;34(5):424-434. doi: 10.1016/j.pedhc.2020.04.007. Epub 2020 Jun 5. — View Citation

Hyacinth HI, Gee BE, Hibbert JM. The Role of Nutrition in Sickle Cell Disease. Nutr Metab Insights. 2010 Jan 1;3:57-67. — View Citation

Ndeezi G, Kiyaga C, Hernandez AG, Munube D, Howard TA, Ssewanyana I, Nsungwa J, Kiguli S, Ndugwa CM, Ware RE, Aceng JR. Burden of sickle cell trait and disease in the Uganda Sickle Surveillance Study (US3): a cross-sectional study. Lancet Glob Health. 201 — View Citation

Nolan VG, Nottage KA, Cole EW, Hankins JS, Gurney JG. Prevalence of vitamin D deficiency in sickle cell disease: a systematic review. PLoS One. 2015 Mar 3;10(3):e0119908. doi: 10.1371/journal.pone.0119908. eCollection 2015. Review. Erratum in: PLoS One. 2015;10(5):e0128853. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of hospitalisation among children with SCD supplemented with vitamin D versus placebo.	Number of children hospitalised during the follow up period and number of hospitalisations per child	3 months follow up
Primary	Effect of vitamin supplementation on serum levels of 25 Hydroxyvitamin D levels in children with SCD	Serum levels of 25 Hydroxyvitamin D	3 months follow up
Primary	Frequency of blood transfusion among children supplemented with vitamin D versus Placebo in children with sickle cell anaemia	The number of children requiring blood transfusion during follow up and the episodes per child	3 months follow up
Secondary	Incidence of vaso-occlusive crises (VOC)	Incidence of painful vaso-occlusive crises	3 months follow up
Secondary	Incidence of acute severe respiratory illnesses	Incidence of cough associated with difficult breathing confirmed as pneumonia or acute chest syndrome by a health worker	3 months follow up
Secondary	Severe adverse events	Serious adverse events for example severe diarrhoea and vomiting with dehydration.	3 months follow up