Effect of Vitamin D Supplementation on Improvement of Pneumonic Children

• Status: Active, not recruiting
• Trial end date: 2020-02-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Children diagnosed clinically with pneumonia according to the World Health Organization criteria of severity.

Exclusion Criteria:

• Children who have clinical signs of rickets.

• Children who have severe illnesses (meningitis, heart or renal disorders, measles)

• Children who have severe malnutrition.

• Children who have endocrine dysfunction, hypercalcemia, hyperthyroidism.

• Children with suspected tuberculosis.

• Children who have received high-dose vitamin D treatment in the past 3 months.

• Children with sufficient or toxic levels of vitamin D.