- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Grace Ndeezi, PhD
- Telefonnummer: +256 772453191
- E-post: gndeezi@gmail.com
Studer Kontakt Backup
- Navn: Ruth Namazzi, MMED
- Telefonnummer: +256 772356331
- E-post: namazzi101@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Frequency of hospitalisation among children with SCD supplemented with vitamin D versus placebo.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months follow up
|
The number of children requiring blood transfusion during follow up and the episodes per child
|
3 months follow up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Incidence of vaso-occlusive crises (VOC)
Tidsramme: 3 months follow up
|
Incidence of painful vaso-occlusive crises
|
3 months follow up
|
Incidence of acute severe respiratory illnesses
Tidsramme: 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
Tidsramme: 3 months follow up
|
Serious adverse events for example severe diarrhoea and vomiting with dehydration.
|
3 months follow up
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Grace Ndeezi, PhD, Makerere University, Kampala, Uganda
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hematologiske sykdommer
- Genetiske sykdommer, medfødte
- Anemi
- Anemi, hemolytisk, medfødt
- Anemi, hemolytisk
- Hemoglobinopatier
- Anemi, sigdcelle
- Fysiologiske effekter av legemidler
- Mikronæringsstoffer
- Vitaminer
- Bone Density Conservation Agents
- Kalsiumregulerende hormoner og midler
- Vitamin d
- Kolekalsiferol
Andre studie-ID-numre
- 2020-117
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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