Zinc Sulfate Acceptability

NCT04039828 | Completed

• 1 other identifier: PR-19033
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction: Zinc (Zn) is an essential mineral widely distributed within the human body with metalloproteins, Zinc-binding proteins, etc. It is necessary for signal transduction and also cell growth and proliferation via respective metallo- and zinc-dependent enzymes. Zinc supplementation can significantly reduce diarrheal severity and duration as well as prevents future incidences and reduces use of other medications in diarrhoea. For this reason WHO, UNICEF, USAID and experts worldwide jointly recommended zinc supplementation (10 mg for infants less than 6 months old and 20 mg in 6 - 59 months old) combined with reduced osmolarity ORS for clinical management of acute diarrhoea. But due to strong metallic taste zinc products are less palatable to children even after using masking flavours as recommended by WHO. Several companies have formulated the product since WHO recommendations came but still transient side effects like vomiting and regurgitation remain evident. Despite careful counselling to the caregivers expected adherence rate to 10 days regimen of zinc supplement is yet to be reached. With the aim to increase zinc supplement coverage during acute diarrheal illness, it is necessary to conduct a study to introduce new formulation Zinc tablet which is more palatable, more dispersible and more acceptable. Intervention: Zinc sulfate \[Zinc Dispersible Tablet, 20 mg; (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet)\] Methods: Prospective, open label, interventional study Hypothesis: Improved formulation of Zinc Sulfate will have good acceptability. Study population: Stratum 1: 3 months - \<18 months = 175 children Stratum 2: 18 months - 59 months = 175 children Objectives:

1. 1.Primary Objective:
2. 2.Secondary objective :

Conditions

Acute Diarrhea

Keywords

Diarrhea; 3 to 59 months children; Zinc tablet; acceptability; adherence; palatability

Outcome Measures

Primary Outcomes (1)

• Acceptability of the Zinc Dispersible Tablet

  The treatment will be considered to have good acceptability if 80% of the prescribed treatment is taken by at least 70% of the children.

  Adherence will be measured on 11th day after enrollment (Following 10 days regimen of investigational Zinc Dispersible Tablet).

Secondary Outcomes (1)

• Taste palatability of Zinc Dispersible Tablet

  Individual daily recorded responses (For 10 days during the drug administration) will be used to arrive at the overall response value on the 5-point pictorial Hedonic scale.

Study Arms (1)

Stratum

EXPERIMENTAL

Stratum 1: From 3 months to \<18 months= 175 Stratum 2: From 18 months to 59 months= 175 In total, 350 participants will be enrolled

Drug: Zinc Sulfate Dispersible Tablet 20 mg (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet)

Interventions

Zinc Sulfate Dispersible Tablet 20 mg (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet) DRUG

Half of the tablet (10 mg) for 3 to 6 months old children and one tablet (20 mg) daily for \> 6 to 59 months old children. The tablet will be dissolved in a teaspoon of safe water or breast milk and administered once daily for 10 days.

Also known as: Zinc, Zinc dispersible tablet

Stratum

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of age 3 - 59 months with an acute diarrhea episode who will be prescribed oral re-hydration salts (ORS) per WHO guidelines
• Residence: within 10 km of the Dhaka Hospital of icddr,b
• Signed informed consent by the guardians/caregivers

You may not qualify if:

• Some or severe dehydration
• Already in the middle of a course of zinc sulfate due a recent previous episode
• Severe acute malnutrition (weight for height \< - 3 z score or bi-pedal edema)
• Congenital anomalies
• Fever or invasive diarrhea or any other medical illness (other than acute diarrhea)
• Having any known medical condition that may interfere with the subject's ability to sense or discriminate between different tastes

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (2)

Dhaka Hospital

Dhaka, Bangladesh

Location

International centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (1)

• Alam J, Nuzhat S, Billal SM, Ahmed T, Khan AI, Hossain MI. Nutritional Profiles and Zinc Supplementation among Children with Diarrhea in Bangladesh. Am J Trop Med Hyg. 2023 Feb 27;108(4):837-843. doi: 10.4269/ajtmh.22-0532. Print 2023 Apr 5.

  PMID: 36848897 DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

Zinc Sulfate; Tablets; Zinc

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Dosage Forms; Pharmaceutical Preparations; Metals, Heavy; Elements; Transition Elements; Metals

Study Officials

• Azharul Islam Khan, PhD, MBBS

  Chief Physician and Head, Hospitals, icddr,b

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stratum 1: From 3 months to \<18 months= 175 Stratum 2: From 18 months to 59 months= 175 in total, 350 participants will be enrolled

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: September 9, 2019
• Primary Completion: March 28, 2020
• Study Completion: September 30, 2020
• Last Updated: February 5, 2021

Record last verified: 2019-07

Locations

BA (2)