Vitamin D Supplementation in Children With Sickle Cell Disease

NCT04662476 | Unknown DMC

• 1 other identifier: 2020-117
• Study Type: interventional
• Target: 662
• Locations: 0 countries
• Sites: N/A

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 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

Conditions

Children With Sickle Cell Disease at Mulago Hospital

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Incidence of vaso-occlusive crises (VOC)

  3 months follow up

• Incidence of acute severe respiratory illnesses

  3 months follow up

• Severe adverse events

  3 months follow up

Study Arms (2)

Vitamin D supplement

ACTIVE COMPARATOR

331 children will each received 60,000IU of vitamin D once a month for 3 months.

Dietary Supplement: Vitamin D3

Intervention

ACTIVE COMPARATOR

The intervention arm will receive vitamin D3.

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 supplement

Intervention; Vitamin D supplement

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Makerere University: lead

Related Publications (4)

• 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.

  PMID: 21537370 BACKGROUND

• 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.

  PMID: 25734582 BACKGROUND

• 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.

  PMID: 32507538 BACKGROUND

• 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.

  PMID: 26833239 RESULT

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Grace Ndeezi, PhD

  Makerere University, Kampala, Uganda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Ndeezi, PhD

CONTACT

+256 772453191; gndeezi@gmail.com

Ruth Namazzi, MMED

CONTACT

+256 772356331; namazzi101@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 331 children will be randomised to the intervention and another 331 to the placebo.

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: May 17, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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