PneumoniaPhase 1Vitamin-DNCT02185196
Vitamin-D Supplementation: Impact on Severe Pneumonia Among Under-five Children
A Phase 1 study testing Vitamin D3 in people with Pneumonia, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Background: Burden: Pneumonia is the leading cause of morbidity and mortality in under-five children, particularly in developing countries. Knowledge gap: Although many studies have reported an association between vitamin D deficiency and pneumonia, there is lack in information on its therapeutic impact, i.e. Read more about this study
- Who is it for?
- Ages 3 to 59 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 1 siteBangladesh
- Study dates
- Jun 2014to 31 Dec 2017
- Phase
- Phase 1
- 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 3 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either sex aged 3 - 59 months, with a clinical diagnosis of severe pneumonia with or without diarrhea.
Who cannot join
- Known case of hypercalcaemia or allergy to vitamin D, as determined by history or previous medical records.
- Congenital Heart disease, evidenced by clinical exam or past medical records.
- Renal or hepatic insufficiency, evidenced by clinical exams or past medical records.
- Known case of tuberculosis, evidenced by medical records
- Known case of asthma, evidenced by history and clinical exam findings.
- Critically ill children requiring ICU care, such as those with septic shock or cardiac arrest or apnoea.
- Received vitamin D or calcium supplementation within the last 4 weeks before current admission, as evidenced by history or medical prescription.
- Any children diagnosed as hypernatraemia during the main phase of the study.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Dhaka Hospital of the International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
About this study
Official title: Vitamin D Supplementation: Impact on Severe Pneumonia Among Under-five Children
Background:
- Burden: Pneumonia is the leading cause of morbidity and mortality in under-five children, particularly in developing countries.
- Knowledge gap: Although many studies have reported an association between vitamin D deficiency and pneumonia, there is lack in information on its therapeutic impact, i.e. the impact of vitamin D supplementation in the management of childhood pneumonia.
- Relevance: Vitamin D plays an important role in modulating the innate immune response against infections. We, therefore, propose to conduct this study to assess the impact of vitamin D supplementation, in addition to standard antibiotic and supportive therapy, on the outcome of severe childhood pneumonia.
Read more
Hypothesis: The investigators hypothesise that in the management of hospitalized severe pneumonia in under-five children, vitamin D3 supplementation, as an adjunct to the standard antibiotic and other supportive therapy, will hasten recover from severe pneumonia and may thereby shorten duration of severe pneumonia and also reduce the risk of new episode of pneumonia.
Objectives: The objective of the investigators study is to assess the clinical benefit of oral supplementation of vitamin D3, in addition to standard antibiotic and other supportive therapy, to hospitalised, under-five children with severe pneumonia.
Methods: This would be a randomised, double blind, controlled clinical trial (RCT). Children of either sex, aged 3-59 months, attending the Dhaka Hospital of icddr,b, with clinically diagnosed severe pneumonia will comprise the study population. Eligible children will be allotted a sequential study number, which will have been previously assigned to vitamin D or placebo in accordance with the randomisation. The study staff and mothers/ caregivers of the children will be blinded as to whether vitamin D3 or placebo has been added to their child's diet. Infants aged 3-5 months will receive breast milk and/or infant formula, and those 6 months or older will receive "Milk Suji" as a complementary food. Vitamin D3 supplementation will be given on five consecutive days, from the day of enrolment in addition to standard antibiotic and other supportive therapy.
Outcome measures/variables:
Primary outcome measure will be time to resolution of severe pneumonia.
Secondary outcome measures will be duration of hospitalization, fever, tachypnoea, chest in drawing, hypoxia, lethargy and inability to feed during hospital stay and as well as new episode of pneumonia after discharge.
Read the detailed description
Hypothesis to be tested:
In a hypothesis testing research proposal, briefly mention the hypothesis to be tested and provide the scientific basis of the hypothesis, critically examining the observations leading to the formulation of the hypothesis.
Does this research proposal involve testing of hypothesis: 0 No 1 Yes (describe below)
The investigators hypothesise that supplementation of vitamin D3 (Cholecalciferol), in addition to standard antibiotic and other supportive therapy in the management of under-five children with severe pneumonia will significantly shorten the duration of severity of pneumonia and thereby reduce hospital stay and also reduce the risk of new episode of pneumonia.
Specific Objectives:
Objective: To assess the clinical benefit of oral vitamin D3 supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalised, under-five children with severe pneumonia.
Primary objective: To compare the duration of severe pneumonia of children in the two study groups receiving the standard therapy (appropriate antibiotic and other supportive therapy) with those receiving vitamin D supplementation in addition to the standard therapy.
Secondary objectives:
- To compare the duration of hospitalization, fever, tachypnoea, chest in drawing, hypoxia, lethargy and inability to feed during hospital stay, in under-five children in the two study groups, as mentioned under the primary aim.
- To compare the recurrence of new episode of pneumonia over the next 6 months after discharge from hospital in the two study groups.
- To identify the optimum safety dose of vitamin D3 for different groups of under-five children.
- In severe pneumonia patient who also have acute watery diarrhoea we will assess the indirect absorption of vitamin D by measuring serum vitamin D level and will also assess the clinical outcome in the subgroup.
- Conditions
- Pneumonia
- Being tested
- Vitamin D3, Placebo
- Keywords
- Vitamin D,, Severe pneumonia,, Under-five children,, Randomised, Controlled, Trial (RCT), Morbidity
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Vigantol-oil
20,000 IU vitamin D3 in children <6 months, 50,000 IU in children 6-12 months and 1,00,000 IU in children 13-59 months of age on first day and thereafter 10,000 IU for next 4 days
PlaceboDrug
Also called Miglyol Oil
20,000 IU Miglyol-oil in children <6 months, 50,000 IU in children 6-12 months and 1,00,000 IU in children 13-59 months of age on first day and thereafter 10,000 IU for next 4 days
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Active comparator | Vitamin D3, Doses form: 20,000 IU vitamin D3 in children <6 months, 50,000 IU in children 6-12 months and 1,00,000 IU in children 13-59 months of age on first day and thereafter 10,000 IU for next 4 days. Receives: Drug: Vitamin D3 |
| Miglyol-oil | Placebo comparator | 20,000 IU Miglyol-oil in children <6 months, 50,000 IU in children 6-12 months and 1,00,000 IU in children 13-59 months of age on first day and thereafter 10,000 IU for next 4 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken for recovery from severe pneumonia
Measured: 12 months
Secondary outcomes (8)
Duration of hospitalization
Measured: 12 months
Time taken for normalisation of temperature
Measured: 12 months
Time taken for normalisation of respiratory rate
Measured: 12 months
Time taken for recovery from chest in drawing
Measured: 12 months
Time taken for oxygen saturation to normalise
Measured: 12 months
Time taken for normalization of mental status
Measured: 12 months
Time taken for normalization of child feeding
Measured: 12 months
Proportion of study children who will develop new episode of pneumonia during the follow up period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJun 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Fahmida Chowdhury, MBBS, MPH, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185196
- Sponsor's protocol ID
- PR-13088
- Acronym
- Vitamin-D
- Status last verified
- Feb 2019
- First submitted
- 22 Jun 2014
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chowdhury F, Shahid ASMSB, Tabassum M, Parvin I, Ghosh PK, Hossain MI, Alam NH, Faruque ASG, Huq S, Shahrin L, Homaira N, Hassan Z, Akhtar Z, Mah-E-Muneer S, Fuchs GJ, Ahmed T, Chisti MJ. Vitamin D supplementation among Bangladeshi children under-five years of age hospitalised for severe pneumonia: A randomised placebo controlled trial. PLoS One. 2021 Feb 19;16(2):e0246460. doi: 10.1371/journal.pone.0246460. eCollection 2021.
PubMed 33606713
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation: Impact on Severe Pneumonia Among Under-five Children
- ClinicalTrials.gov ID
- NCT02185196
- Acronym / sponsor ID
- Vitamin-D / PR-13088
- Conditions
- Pneumonia
- Keywords
- Vitamin D,, Severe pneumonia,, Under-five children,, Randomised, Controlled, Trial (RCT), Morbidity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jun 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 9 Jul 2014 (estimated)
- 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.
Background:
- Burden: Pneumonia is the leading cause of morbidity and mortality in under-five children, particularly in developing countries.
- Knowledge gap: Although many studies have reported an association between vitamin D deficiency and pneumonia, there is lack in information on its therapeutic impact, i.e. the impact of vitamin D supplementation in the management of childhood pneumonia.
- Relevance: Vitamin D plays an important role in modulating the innate immune response against infections. We, therefore, propose to conduct this study to assess the impact of vitamin D supplementation, in addition to standard antibiotic and supportive therapy, on the outcome of severe childhood pneumonia.
Hypothesis: The investigators hypothesise that in the management of hospitalized severe pneumonia in under-five children, vitamin D3 supplementation, as an adjunct to the standard antibiotic and other supportive therapy, will hasten recover from severe pneumonia and may thereby shorten duration of severe pneumonia and also reduce the risk of new episode of pneumonia.
Objectives: The objective of the investigators study is to assess the clinical benefit of oral supplementation of vitamin D3, in addition to standard antibiotic and other supportive therapy, to hospitalised, under-five children with severe pneumonia.
Methods: This would be a randomised, double blind, controlled clinical trial (RCT). Children of either sex, aged 3-59 months, attending the Dhaka Hospital of icddr,b, with clinically diagnosed severe pneumonia will comprise the study population. Eligible children will be allotted a sequential study number, which will have been previously assigned to vitamin D or placebo in accordance with the randomisation. The study staff and mothers/ caregivers of the children will be blinded as to whether vitamin D3 or placebo has been added to their child's diet. Infants aged 3-5 months will receive breast milk and/or infant formula, and those 6 months or older will receive "Milk Suji" as a complementary food. Vitamin D3 supplementation will be given on five consecutive days, from the day of enrolment in addition to standard antibiotic and other supportive therapy.
Outcome measures/variables:
Primary outcome measure will be time to resolution of severe pneumonia.
Secondary outcome measures will be duration of hospitalization, fever, tachypnoea, chest in drawing, hypoxia, lethargy and inability to feed during hospital stay and as well as new episode of pneumonia after discharge.
Detailed description
Hypothesis to be tested:
In a hypothesis testing research proposal, briefly mention the hypothesis to be tested and provide the scientific basis of the hypothesis, critically examining the observations leading to the formulation of the hypothesis.
Does this research proposal involve testing of hypothesis: 0 No 1 Yes (describe below)
The investigators hypothesise that supplementation of vitamin D3 (Cholecalciferol), in addition to standard antibiotic and other supportive therapy in the management of under-five children with severe pneumonia will significantly shorten the duration of severity of pneumonia and thereby reduce hospital stay and also reduce the risk of new episode of pneumonia.
Specific Objectives:
Objective: To assess the clinical benefit of oral vitamin D3 supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalised, under-five children with severe pneumonia.
Primary objective: To compare the duration of severe pneumonia of children in the two study groups receiving the standard therapy (appropriate antibiotic and other supportive therapy) with those receiving vitamin D supplementation in addition to the standard therapy.
Secondary objectives:
- To compare the duration of hospitalization, fever, tachypnoea, chest in drawing, hypoxia, lethargy and inability to feed during hospital stay, in under-five children in the two study groups, as mentioned under the primary aim.
- To compare the recurrence of new episode of pneumonia over the next 6 months after discharge from hospital in the two study groups.
- To identify the optimum safety dose of vitamin D3 for different groups of under-five children.
- In severe pneumonia patient who also have acute watery diarrhoea we will assess the indirect absorption of vitamin D by measuring serum vitamin D level and will also assess the clinical outcome in the subgroup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Active comparator | Drug: Vitamin D3Vitamin D3, Doses form: 20,000 IU vitamin D3 in children <6 months, 50,000 IU in children 6-12 months and 1,00,000 IU in children 13-59 months of age on first day and thereafter 10,000 IU for next 4 days. |
| Miglyol-oil | Placebo comparator | Drug: Placebo20,000 IU Miglyol-oil in children <6 months, 50,000 IU in children 6-12 months and 1,00,000 IU in children 13-59 months of age on first day and thereafter 10,000 IU for next 4 days. |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children of either sex aged 3 - 59 months, with a clinical diagnosis of severe pneumonia with or without diarrhea.
Key exclusion criteria (8 listed)
- Known case of hypercalcaemia or allergy to vitamin D, as determined by history or previous medical records.
- Congenital Heart disease, evidenced by clinical exam or past medical records.
- Renal or hepatic insufficiency, evidenced by clinical exams or past medical records.
- Known case of tuberculosis, evidenced by medical records
- Known case of asthma, evidenced by history and clinical exam findings.
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 D3Also: Vigantol-oil20,000 IU vitamin D3 in children <6 months, 50,000 IU in children 6-12 months and 1,00,000 IU in children 13-59 months of age on first day and thereafter 10,000 IU for next 4 days | Drug | Vitamin D3 |
| PlaceboAlso: Miglyol Oil20,000 IU Miglyol-oil in children <6 months, 50,000 IU in children 6-12 months and 1,00,000 IU in children 13-59 months of age on first day and thereafter 10,000 IU for next 4 days | Drug | Miglyol-oil |
Primary outcome
Time taken for recovery from severe pneumonia
Time frame: 12 months
8 secondary outcomes
Duration of hospitalization
Time frame: 12 months
Time taken for normalisation of temperature
Time frame: 12 months
Time taken for normalisation of respiratory rate
Time frame: 12 months
Time taken for recovery from chest in drawing
Time frame: 12 months
Time taken for oxygen saturation to normalise
Time frame: 12 months
Time taken for normalization of mental status
Time frame: 12 months
Time taken for normalization of child feeding
Time frame: 12 months
Proportion of study children who will develop new episode of pneumonia during the follow up period
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 33606713Chowdhury F, Shahid ASMSB, Tabassum M, Parvin I, Ghosh PK, Hossain MI, Alam NH, Faruque ASG, Huq S, Shahrin L, Homaira N, Hassan Z, Akhtar Z, Mah-E-Muneer S, Fuchs GJ, Ahmed T, Chisti MJ. Vitamin D supplementation among Bangladeshi children under-five years of age hospitalised for severe pneumonia: A randomised placebo controlled trial. PLoS One. 2021 Feb 19;16(2):e0246460. doi: 10.1371/journal.pone.0246460. eCollection 2021.
Related trials for Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
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.
Fahmida Chowdhury, MBBS, MPH principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D3 in people with Pneumonia, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken for recovery from severe pneumonia (time frame: 12 months). 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 NCT02185196, which also lists 1 linked publication.
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 6 Aug 2019.