Zinc Sulfate Acceptability

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. Primary Objective:

Acceptability of the zinc product in the management of childhood diarrhea will be assessed by observing:

i) Incidence of vomiting or regurgitation among enrolled children receiving the improvised zinc formulation.

ii) The adherence: The number of days (out of the total 10 days) the child took the protocol-prescribed dose of the medicine. The treatment will be considered to have good acceptability if at least 80% of the prescribed treatment is taken by at least 70% of the children over the duration of 10 days, as per WHO guidelines.
2. Secondary objective :

To assess palatability Secondary end point evaluation (Palatability): The statistical analysis will comprise the calculation of the percentage of patients out of 350 who found the investigational product to have "very well-tolerated, well-tolerated or tolerated" scores (i.e. any of the upper 3 possible scores). A 95% confidence interval, using the normal approximation of the binomial distribution, will be calculated for the percentage.

Conditions

• Acute Diarrhea

Interventions

DRUG

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

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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh

  lead OTHER

Principal Investigators

• Azharul Islam Khan, PhD, MBBS · Chief Physician and Head, Hospitals, icddr,b

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

3 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-09

Primary Completion

2020-03-28

Completion

2020-09-30

Countries

• Bangladesh

Study Locations