Children With Sickle Cell Disease at Mulago HospitalVIDSNCT04662476
Vitamin D Supplementation in Children With Sickle Cell Disease
A study testing Vitamin D3 in people with Children With Sickle Cell Disease at Mulago Hospital, run by Makerere University.
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. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Children With Sickle Cell Disease at Mulago Hospital
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 662 participants
- Where
- No sites listed yet
- Study dates
- 17 May 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Vitamin D Supplementation on Sickle Cell Disease Hospitalisation and Related Complications Among Children in Mulago Hospital: A Randomised Clinical Trial
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
Read the detailed 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.
- Being tested
- Vitamin D3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Vitamin D3 supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplement | Active comparator | 331 children will each received 60,000IU of vitamin D once a month for 3 months. Receives: Dietary Supplement: Vitamin D3 |
| Intervention | Active comparator | The intervention arm will receive vitamin D3. Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 months follow up
Secondary outcomes (3)
Incidence of vaso-occlusive crises (VOC)
Incidence of painful vaso-occlusive crises
Measured: 3 months follow up
Incidence of acute severe respiratory illnesses
Incidence of cough associated with difficult breathing confirmed as pneumonia or acute chest syndrome by a health worker
Measured: 3 months follow up
Severe adverse events
Serious adverse events for example severe diarrhoea and vomiting with dehydration.
Measured: 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start17 May 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Children With Sickle Cell Disease at Mulago HospitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 331 children will be randomised to the intervention and another 331 to the placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 662 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, College of Health Sciences, Makerere University
- Investigators
- Grace Ndeezi, PhD, Principal investigator, Makerere University, Kampala, Uganda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662476
- Sponsor's protocol ID
- 2020-117
- Acronym
- VIDS
- Status last verified
- Apr 2021
- First submitted
- 4 Dec 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant information may be shared with other researchers.
Publications
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.
PubMed 21537370Nolan 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.
PubMed 25734582Dougherty 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.
PubMed 32507538Ndeezi 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.
PubMed 26833239
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Sickle Cell Disease Hospitalisation and Related Complications Among Children in Mulago Hospital: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04662476
- Acronym / sponsor ID
- VIDS / 2020-117
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 662 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 17 May 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 331 children will be randomised to the intervention and another 331 to the placebo.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplement | Active comparator | Dietary Supplement: Vitamin D3331 children will each received 60,000IU of vitamin D once a month for 3 months. |
| Intervention | Active comparator | Dietary Supplement: Vitamin D3The intervention arm will receive vitamin D3. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Vitamin D3 supplement | Dietary supplement | Intervention, Vitamin D supplement |
Primary outcome
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
3 secondary outcomes
Incidence of vaso-occlusive crises (VOC)
Time frame: 3 months follow up
Incidence of acute severe respiratory illnesses
Time frame: 3 months follow up
Severe adverse events
Time frame: 3 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Background: PubMed 21537370Hyacinth 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.
- Background: PubMed 25734582Nolan 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.
- Background: PubMed 32507538Dougherty 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.
- Results publication: PubMed 26833239Ndeezi 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.
- Individual participant dataSharing planned: Yes. De-identified participant information may be shared with other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Ndeezi, PhD principal investigator
Makerere University, Kampala, Uganda
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Children With Sickle Cell Disease at Mulago Hospital, run by Makerere University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grace Ndeezi, PhD (+256 772453191, gndeezi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hospitalisation among children with SCD supplemented with vitamin D versus placebo. (time frame: 3 months follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662476, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.