Effect of Vitamin D Supplementation on Improvement of Pneumonic Children

NCT04244474 | Unknown Phase 1

• 1 other identifier: D-12-2019
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

vitamin D3 supplementation

EXPERIMENTAL

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.

Drug: A single one ml injection

Placebo

PLACEBO COMPARATOR

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.

Drug: A single one ml injection

Interventions

A single one ml injection DRUG

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).

Also known as: Supplementation

Placebo; vitamin D3 supplementation

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

Location

Related Publications (1)

• Labib JR, Ibrahem SK, Ismail MM, Fatah SAMAE, Sedrak AS, Attia MAS, El-Hanafi HM, Kamel MH. Vitamin D supplementation and improvement of pneumonic children at a tertiary pediatric hospital in Egypt: A randomized controlled trial. Medicine (Baltimore). 2021 Apr 2;100(13):e25011. doi: 10.1097/MD.0000000000025011.

  PMID: 33787584 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Pneumonia

Interventions

Injections; Dietary Supplements

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• John R Labib, Ass.Prof.

  Pediatrics Department, Faculty of Medicine, Cairo University

  STUDY CHAIR

• Shaimaa AM AbdElFatah, Ass.Prof.

  Public Health Department,Faculty of Medicine, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 28, 2020
• Study Start: September 9, 2019
• Primary Completion: December 15, 2019
• Study Completion: February 15, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)