Vitamin-D Supplementation: Impact on Severe Pneumonia Among Under-five Children

NCT02185196 | Completed Phase 1 DMC

• 1 other identifier: PR-13088
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pneumonia

Keywords

Vitamin D,; Severe pneumonia,; Under-five children,; Randomised; Controlled; Trial (RCT); Morbidity

Outcome Measures

Primary Outcomes (1)

• Time taken for recovery from severe pneumonia

  12 months

Secondary Outcomes (8)

• Duration of hospitalization

  12 months

• Time taken for normalisation of temperature

  12 months

• Time taken for normalisation of respiratory rate

  12 months

• Time taken for recovery from chest in drawing

  12 months

• Time taken for oxygen saturation to normalise

  12 months

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Vitamin D3 DRUG

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

Also known as: Vigantol-oil

Vitamin D3

Placebo DRUG

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

Also known as: Miglyol Oil

Miglyol-oil

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of either sex aged 3 - 59 months, with a clinical diagnosis of severe pneumonia with or without diarrhea.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Dhaka Hospital of the International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 33606713 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Fahmida Chowdhury, MBBS, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2014
• First Posted: July 9, 2014
• Study Start: June 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 6, 2019

Record last verified: 2019-02

Locations

BA (1)