Zinc Sulfate Acceptability

• Status: Completed
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Treatments: Zinc; Zinc Sulfate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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