NCT02185196: Vitamin-D

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

Completed Phase 1 Last updated 5 August 2019

What this trial tests

Phase 1 trial testing Vitamin D3 in Pneumonia in 197 participants. Completed in 31 December 2017.

Timeline

1 June 2014

Primary endpoint
31 December 2017

31 December 2017

Quick facts

Lead sponsor	International Centre for Diarrhoeal Disease Research, Bangladesh
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	197
Start date	1 June 2014
Primary completion	31 December 2017
Estimated completion	31 December 2017
Sites	1 location across Bangladesh

Drugs / interventions tested

• Vitamin D3 (cholecalciferol) — full drug profile →
• Placebo

Conditions studied

• Pneumonia — all drugs for Pneumonia →

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh — full company profile →

Who can join

Adults 3 Months to 59 Months, any sex, with Pneumonia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time taken for recovery from severe pneumonia
  Time frame: 12 months

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of Vitamin D in Preventing and Treating Selected Extraskeletal Diseases-An Umbrella Review.
   Maretzke F, Bechthold A, Egert S, Ernst JB, et al · · 2020 · cited 68× · PMID 32244496 · DOI 10.3390/nu12040969
2. Vitamin D as an adjunct to antibiotics for the treatment of acute childhood pneumonia.
   Das RR, Singh M, Naik SS. · · 2018 · cited 33× · PMID 30024634 · DOI 10.1002/14651858.cd011597.pub2
3. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age.
   Huey SL, Acharya N, Silver A, Sheni R, et al · · 2020 · cited 30× · PMID 33305842 · DOI 10.1002/14651858.cd012875.pub2
4. Vitamin D supplementation among Bangladeshi children under-five years of age hospitalised for severe pneumonia: A randomised placebo controlled trial.
   Chowdhury F, Shahid ASMSB, Tabassum M, Parvin I, et al · · 2021 · cited 11× · PMID 33606713 · DOI 10.1371/journal.pone.0246460