Effects of vitamin D supplementation to children diagnosed with pneumonia in Kabul: a randomised controlled trial

Archives of Disease in Childhood

Apr 2010

DOI: 10.1111/j.1365-3156.2010.02578.x

Citations:189

Influential Citations:9

Interventional (Human) Studies

Enhanced Details

Methods

Double-blind, individually randomized, placebo-controlled trial at Maywand Hospital, Kabul. Participants: 453 children aged 1–36 months with clinically diagnosed pneumonia (non-severe or severe) at outpatient clinic; excluded: rickets, other concurrent severe diseases, very severe pneumonia or wheeze. All received antibiotic treatment per IMCI guidelines. Follow-up to 90 days. Intention-to-treat analysis; 224 allocated to vitamin D and 229 to placebo.

Intervention

Single oral dose of 100,000 IU vitamin D3 (cholecalciferol) delivered as olive-oil drops in a sealed syringe, given once at a clinical visit, alongside standard antibiotic therapy.

Results

Index pneumonia recovery time did not differ (mean 4.74 days with vitamin D vs 4.98 days with placebo; P = 0.17). Vitamin D reduced the risk of a repeat pneumonia episode within 90 days (92/204 in vitamin D vs 122/211 in placebo; relative risk 0.78; 95% CI 0.64–0.94; P = 0.01) and extended time to recurrence (median 72 days vs 59 days; HR 0.71; 95% CI 0.53–0.95; P = 0.02). Three deaths occurred during the 90-day follow-up; no adverse events attributed to vitamin D. Conclusion: A single high-dose vitamin D supplementation alongside antibiotics may reduce recurrence of pneumonia in young children in this high-deficiency setting.

Limitations

Limitations: Lack of radiographic confirmation of pneumonia; reliance on IMCI clinical criteria with potential misclassification of viral infections; baseline vitamin D status not measured due to cost/technical constraints; single-center study in Kabul limiting generalizability; follow-up limited to 90 days; study powered for detecting differences in duration of the index episode, not recurrence; no assessment of longer-term safety beyond the study period.

Abstract

Aim Vitamin D has a role in regulating immune function and deficiency is a risk factor for childhood pneumonia. The authors investigated whether: (1) Supplementation of 100 000 IU of vitamin D3 (cholecalciferol) along with antibiotics reduces the duration of illness in children with pneumonia; (2) vitamin D3 supplementation reduces the risk of repeat episodes. Methods Design: Double-blind individually randomised placebo-controlled trial. Setting: Outpatient clinics and inpatient department in an inner-city Kabul hospital, Afghanistan. Participants: 453, 1–36 months old children, from an area with known high vitamin D deficiency, clinically diagnosed with non-severe or severe pneumonia (WHO’s IMCI diagnostic criteria) at the outpatient clinic from December 2006 to February 2007. Exclusions: Children diagnosed with rickets, other concurrent severe diseases, very severe pneumonia or wheeze. Intervention: Identical-looking syringes with unique identifiers containing vitamin D3 or placebo were randomised and administered orally at diagnosis with regular pneumonia treatment. Follow-up: Daily until signs of pneumonia resolved and then two-weekly for 3 months. Outcome measure: (1) Mean number of days recovery (resolution of IMCI signs of pneumonia) ascertained through daily home-visit or inpatient examinations; (2) incidence of repeat episodes of pneumonia from 14–90 days after the resolution of the index episode ascertained through two-weekly home visits and passive case detection at the outpatients. Results 224 received vitamin D3 and 229 placebo; randomisation successful with balanced background characteristics in the two arms. Intention to treat survival analysis: (1) No significant difference in the mean number of days to recovery between the vitamin D3 (4.74 days; SD 2.22) and placebo arms (4.98 days; SD 2.89), p=0.17. (2) Risk of a repeat episode of pneumonia within 90 days of supplementation lower in the vitamin D3 (92/204; 45%) compared to the placebo group (122/211; 58%) (RR 0.78; 95% CI 0.64 to 0.94; p=0.01). Vitamin D3 arm went longer without experiencing a repeat episode of pneumonia (mean 72 days vs 59 days; HR 0.71; 95% CI 0.53 to 0.95; p=0.02). Conclusion A single high-dose oral vitamin D3 supplementation to young children along with antibiotic treatment for pneumonia does not affect length of pneumonia, but reduces the risk of recurrence of pneumonia episodes. show less