Vitamin D Supplementation in Children With Sickle Cell Disease (VIDS)
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|ClinicalTrials.gov Identifier: NCT04662476|
Recruitment Status : Not yet recruiting
First Posted : December 10, 2020
Last Update Posted : April 13, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Children With Sickle Cell Disease at Mulago Hospital||Dietary Supplement: Vitamin D3||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||662 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||331 children will be randomised to the intervention and another 331 to the placebo.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The sachets containing vitamin D will be exactly similar to the ones containing the placebo. Both the intervention and placebo granules will be identical in colour, odour, taste and amount. Children will be randomized into treatment groups by order of entry in the study, based on a pre-determined blinded randomization list created and managed by an independent statistician.|
|Official Title:||Effect of Vitamin D Supplementation on Sickle Cell Disease Hospitalisation and Related Complications Among Children in Mulago Hospital: A Randomised Clinical Trial|
|Estimated Study Start Date :||May 17, 2021|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||January 31, 2022|
Active Comparator: Vitamin D supplement
331 children will each received 60,000IU of vitamin D once a month for 3 months.
Dietary Supplement: Vitamin D3
Vitamin D3 supplement
Active Comparator: Intervention
The intervention arm will receive vitamin D3.
Dietary Supplement: Vitamin D3
Vitamin D3 supplement
- Frequency of hospitalisation among children with SCD supplemented with vitamin D versus placebo. [ Time Frame: 3 months follow up ]Number of children hospitalised during the follow up period and number of hospitalisations per child
- Effect of vitamin supplementation on serum levels of 25 Hydroxyvitamin D levels in children with SCD [ Time Frame: 3 months follow up ]Serum levels of 25 Hydroxyvitamin D
- Frequency of blood transfusion among children supplemented with vitamin D versus Placebo in children with sickle cell anaemia [ Time Frame: 3 months follow up ]The number of children requiring blood transfusion during follow up and the episodes per child
- Incidence of vaso-occlusive crises (VOC) [ Time Frame: 3 months follow up ]Incidence of painful vaso-occlusive crises
- Incidence of acute severe respiratory illnesses [ Time Frame: 3 months follow up ]Incidence of cough associated with difficult breathing confirmed as pneumonia or acute chest syndrome by a health worker
- Severe adverse events [ Time Frame: 3 months follow up ]Serious adverse events for example severe diarrhoea and vomiting with dehydration.
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|Ages Eligible for Study:||6 Months to 12 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662476
|Contact: Grace Ndeezi, PhD||+256 email@example.com|
|Contact: Ruth Namazzi, MMED||+256 firstname.lastname@example.org|
|Principal Investigator:||Grace Ndeezi, PhD||Makerere University, Kampala, Uganda|
|Responsible Party:||College of Health Sciences, Professor, Makerere University|
|Other Study ID Numbers:||
|First Posted:||December 10, 2020 Key Record Dates|
|Last Update Posted:||April 13, 2021|
|Last Verified:||April 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||De-identified participant information may be shared with other researchers.|
Clinical Study Report (CSR)
|Time Frame:||within one year and the sharing period could extend beyond this period|
|Access Criteria:||If requested by other researchers who have carried out similar studies for a meta-analysis|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents