Effect of Vitamin D Supplementation on Improvement of Pneumonic Children

Summary

In Egypt, according to UNICEF 2018, Acute Respiratory Tract Infection (ARTIs)was estimated to account for 11% and 19% of the under-five and post-neonatal mortalities respectively.

Despite the well-recognized role of vitamin D in metabolism and homeostasis in the general population, there is now growing interest in its probable association with pneumonia.

Globally, about 30% to 90% of Under-5 children experience vitamin D deficiency. This could vary among children, according to the socioeconomic, environmental and behavioral circumstances.

Studies evaluating the association of 1,25 (OH)2D deficiency and the severity of respiratory tract infection, are rare and showed controversial findings.

However, an Indian systematic review polled the results of 12 studies, with 2279 participants, highlighted the significant correlation between vitamin D deficiency and incidence and severity of ALRIs.

A prospective cohort study conducted in Yemen examined the ability of deficient levels of vit.D to predict the outcomes of severe pneumonia. The study documented the significant association between vitamin D deficiency with neutropenia and hypoxia in patients with severe pneumonia, thus predicting the poor prognosis.

In Egypt 2010, a case-control study conducted on children aged 2 to 5 years to examine the impact of vitamin D deficiency on the susceptibility of pneumonia. The study illustrated that Vitamin D deficiency is associated with a higher incidence and more severe pneumonia.

Recent studies advocated providing children(particularly suffering from pneumonia) with adequate amounts of vitamin D supplements.

Nevertheless, few studies have been conducted to evaluate the impact of vitamin D supplementation on the outcome of pneumonic infants.

Thus, we urge to conduct a randomized controlled trial (RCT) in Abou ElReesh tertiary Pediatric hospital, to evaluate the effects of vitamin D3 supplementation to children with pneumonia. We postulated that supplementation of 100 000 IU of vitamin D3 (Cholecalciferol) will reduce the duration of illness in those children and improve their outcome.

Conditions

• Child, Hospitalized
• Vitamin D Deficiency
• Pneumonia

Interventions

DRUG

A single one ml injection

All children were treated with antibiotics according to WHO classification and treatment of childhood pneumonia at health facilities 2012 \[18\], at enrollment after obtaining consent from parents and completing the baseline assessment, children were given a single injection of one ml of 100.000 IU of vitamin D3 (Cholecalciferol), vitamin D3 obtained from 2 ml vials containing 200,000 IU each (Devarol- S- 200.000 I.U. produced by Memphis for Pharmaceutical and Chemical Industries) and stored in manufacturer's recommended conditions in a dry, cool environment for 1-16 weeks (depending on the date of recruitment) or placebo which is 1 ml saline injection. Syringes were labeled with a unique ID number and given by the blinded doctors choosing the next syringe with a randomization code. (only office secretary aware of randomization codes).

Sponsors & Collaborators

• Cairo University

  lead OTHER

Principal Investigators

• John R Labib, Ass.Prof. · Pediatrics Department, Faculty of Medicine, Cairo University

• Shaimaa AM AbdElFatah, Ass.Prof. · Public Health Department,Faculty of Medicine, Cairo University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-09

Primary Completion

2019-12-15

Completion

2020-02-15

Countries

• Egypt

Study Locations