Pneumonia Clinical Trial
Official title:
Randomized Controlled Trial of Vitamin D Supplementation on Improvement of Pneumonic Children at Tertiary Pediatric Hospital in Egypt
Verified date | January 2020 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 191 |
Est. completion date | February 15, 2020 |
Est. primary completion date | December 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 12 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine, Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in serum level of 25hydroxycholecalciferol (25(OH)D) | Patients' percent change of Vitamin D (25 (OH)D) will be calculated to quantify the change levels before and after vitamin D3 (Cholecalciferol) administration through the equation: Pediatric, Blood Vitamin D level (BVD) %change = [(BVD after - BVD before) ÷ BVD before] × 100 |
At baseline and 7 days after vitamin D3 (Cholecalciferol) injection |
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