Randomized Controlled Trial of Vitamin D Supplementation on Improvement of Pneumonic Children at Tertiary Pediatric Hospital in Egypt
试验速览
- 阶段
- 1 期
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Change in serum level of 25hydroxycholecalciferol (25(OH)D)
研究概览
简要总结
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.
详细描述
Subjects and Methods:
Study design and study setting The current study is a randomized, double-blinded placebo-controlled trial (RCT) that was conducted in Cairo University Abou ElReesh Children hospital, which is a university-affiliated teaching hospital in Egypt, to evaluate the effect of vitamin D3 supplementation on the outcome of treatment of children with pneumonia. Pneumonia cases were recruited from two of the hospital general pediatric departments and the four pediatric intensive care units (PICUs) of the hospital.
Sample Size and study population To detect a 20% difference in the mean duration of pneumonia between the vitamin D arm and control arm [5 days vs. 6 days (SD 2)] allowing Type I error of 5% and Type II error of 10%, 86 per group (172 total) is the minimum number to be recruited. After allowing for 10% for nonresponse or loss for follow-up and 25% for the exclusion of children diagnosed with sufficient or toxic level of vitamin D after vitamin D testing (Box 1) according to the prevalence of vitamin deficiency in a pediatric hospital of eastern India, 233 was the minimum number to start with.
Mild and moderate pneumonia cases were recruited from two of the hospital general pediatric departments chosen by a simple random sample from a total of six hospital departments while severe pneumonia cases were recruited from the four PICUs of the hospital.
All children (259 children) between 1 month and 12 years of age admitted to the selected departments during the period from 9th September 2019 to 15th December 2019 and diagnosed clinically with pneumonia according to the World Health Organization criteria of severity (Box 2) were screened for the inclusion criteria. Children who had clinical signs of rickets (2 children), severe illnesses (meningitis, heart or renal disorders, measles, severe malnutrition, endocrine dysfunction, hypercalcemia, hyperthyroidism, and suspected tuberculosis) (4 children) or were known to have received high-dose vitamin D treatment in the past 3 months (3 children) were excluded from the study. Children with sufficient (52 children) or toxic (7 children) levels of vitamin D were also excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed clinically with pneumonia according to the World Health Organization criteria of severity.
排除标准
- •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.
研究组 & 干预措施
vitamin D3 supplementation
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) . Syringes were labeled with a unique ID number and given by the blinded doctors choosing the next syringe with a randomization code.
干预措施: A single one ml injection (Drug)
Placebo
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 saline injection. Syringes were labeled with a unique ID number and given by the blinded doctors choosing the next syringe with a randomization code.
干预措施: A single one ml injection (Drug)
结局指标
主要结局
Change in serum level of 25hydroxycholecalciferol (25(OH)D)
时间窗: At baseline and 7 days after vitamin D3 (Cholecalciferol) injection
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
次要结局
未报告次要终点
研究者
Shaimaa Ali Mohamed Abd El Fatah
Assistant Professor
Cairo University