Daily Zinc Supplement Effect on Prevention of Diarrhea and Acute Respiratory Infections in Children Less Than Five Years

NCT05002101 | Completed Phase 4

• 1 other identifier: MD180 2018
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Zinc deficiency in children is a major problem which leads to compromised immunity and accordingly repeated infections. This study aims to investigate the effect of supplementing zinc to decrease the incidence of diarrhea and respiratory illness in children between 6 months and 5 years in Paediatric Outpatient Clinic in Ain Shams University Hospital.

Conditions

Zinc Deficiency; Child Nutrition Disorders

Keywords

zinc; diarrhea; Respiratory Tract Infections; prevention

Outcome Measures

Primary Outcomes (2)

• Change in the baseline cumulative incidence rate of diarrhea at 4 months

  Cumulative incidence rate of diarrhea at the baseline before intervention was compared to the cumulative incidence rate of diarrhea after 4 months of daily zinc supplements administration

  after 4 months

• Change in the baseline cumulative incidence rate of acute respiratory infections at 4 months

  Cumulative incidence rate of acute respiratory infections at the baseline before intervention was compared to the cumulative incidence rate of acute respiratory infections after 4 months of daily zinc supplements administration.

  after 4 months

Study Arms (2)

zinc group

ACTIVE COMPARATOR

The children were randomized to receive daily zinc sulphate. The elemental zinc dose was 3 mg/ day to children whose weight is less than 10 kg and 7 mg/ day to children whose weight is 10 kg or more.

Dietary Supplement: zinc

placebo group

PLACEBO COMPARATOR

The placebo was non-nutritious and vitamin-free, designed to be identical to the zinc syrup in colour, odour, consistency and taste. Zinc and placebo syrups were packaged in similar bottles.

Drug: Placebo

Interventions

zinc DIETARY_SUPPLEMENT

The zinc syrup was prepared with a concentration of 7 mg zinc in each 5 ml solution. Accordingly, children with weight more than 10 kg were asked to take 5 ml syrup daily, while children with weight less than 10 kg were asked to take 2.5 ml daily.

Also known as: zinc sulphate

zinc group

Placebo DRUG

Children with weight more than 10 kg were asked to take 5 ml syrup daily, while children with weight less than 10 kg were asked to take 2.5 ml daily.

Also known as: inactive substance

placebo group

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Apparently healthy child with good general health

You may not qualify if:

• Children with severe malnutrition requiring hospital admission,
• Cases of chronic and metabolic diseases as diabetic children
• Children suffering from any type of cancer or any other debilitating disease.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Pediatric outpatient clinic in Ain Shams University hospital

Cairo, Egypt

Location

Related Publications (2)

• Liberato SC, Singh G, Mulholland K. Zinc supplementation in young children: A review of the literature focusing on diarrhoea prevention and treatment. Clin Nutr. 2015 Apr;34(2):181-8. doi: 10.1016/j.clnu.2014.08.002. Epub 2014 Aug 13.

  PMID: 25176404 RESULT

• Abd El-Ghaffar YS, Shouman AE, Hakim SA, El Gendy YGA, Wahdan MMM. Effect of Zinc Supplementation in Children Less Than 5 Years on Diarrhea Attacks: A Randomized Controlled Trial. Glob Pediatr Health. 2022 Jun 17;9:2333794X221099266. doi: 10.1177/2333794X221099266. eCollection 2022.

  PMID: 35747897 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders; Diarrhea; Respiratory Tract Infections

Interventions

Zinc; Zinc Sulfate

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Zinc Compounds

Study Officials

• Ahmed E Shouman, Professor

  Faculty of Medicine, Ain-Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study was single-blinded, where the children's mothers didn't know either their children are enrolled in the study group or the control group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of public health - Department of Community, Environmental and Occupational Medicine

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 12, 2021
• Study Start: August 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2020
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)