- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04662476
Vitamin D Supplementation in Children With Sickle Cell Disease (VIDS)
Effect of Vitamin D Supplementation on Sickle Cell Disease Hospitalisation and Related Complications Among Children in Mulago Hospital: A Randomised Clinical Trial
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Grace Ndeezi, PhD
- Telefonnummer: +256 772453191
- E-post: gndeezi@gmail.com
Studera Kontakt Backup
- Namn: Ruth Namazzi, MMED
- Telefonnummer: +256 772356331
- E-post: namazzi101@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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 Criteria:
- 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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Vitamin D supplement
331 children will each received 60,000IU of vitamin D once a month for 3 months.
|
Vitamin D3 supplement
|
Aktiv komparator: Intervention
The intervention arm will receive vitamin D3.
|
Vitamin D3 supplement
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Frequency of hospitalisation among children with SCD supplemented with vitamin D versus placebo.
Tidsram: 3 months follow up
|
Number of children hospitalised during the follow up period and number of hospitalisations per child
|
3 months follow up
|
Effect of vitamin supplementation on serum levels of 25 Hydroxyvitamin D levels in children with SCD
Tidsram: 3 months follow up
|
Serum levels of 25 Hydroxyvitamin D
|
3 months follow up
|
Frequency of blood transfusion among children supplemented with vitamin D versus Placebo in children with sickle cell anaemia
Tidsram: 3 months follow up
|
The number of children requiring blood transfusion during follow up and the episodes per child
|
3 months follow up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Incidence of vaso-occlusive crises (VOC)
Tidsram: 3 months follow up
|
Incidence of painful vaso-occlusive crises
|
3 months follow up
|
Incidence of acute severe respiratory illnesses
Tidsram: 3 months follow up
|
Incidence of cough associated with difficult breathing confirmed as pneumonia or acute chest syndrome by a health worker
|
3 months follow up
|
Severe adverse events
Tidsram: 3 months follow up
|
Serious adverse events for example severe diarrhoea and vomiting with dehydration.
|
3 months follow up
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Grace Ndeezi, PhD, Makerere University, Kampala, Uganda
Publikationer och användbara länkar
Allmänna publikationer
- Hyacinth HI, Gee BE, Hibbert JM. The Role of Nutrition in Sickle Cell Disease. Nutr Metab Insights. 2010 Jan 1;3:57-67. doi: 10.4137/NMI.S5048.
- 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. Erratum In: PLoS One. 2015;10(5):e0128853.
- 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.
- 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. 2016 Mar;4(3):e195-200. doi: 10.1016/S2214-109X(15)00288-0. Epub 2016 Jan 29.
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2020-117
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