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Zinc Sulfate Acceptability

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ClinicalTrials.gov Identifier: NCT04039828
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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. 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.


Condition or disease Intervention/treatment Phase
Acute Diarrhea Drug: Zinc Sulfate Dispersible Tablet 20 mg (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

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

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zinc Sulfate Acceptability Study in Children With Acute Diarrhea: A Prospective, Open-label, Interventional Study
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Stratum

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)
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.
Other Name: Zinc, Zinc dispersible tablet




Primary Outcome Measures :
  1. Acceptability of the Zinc Dispersible Tablet [ Time Frame: Adherence will be measured on 11th day after enrollment (Following 10 days regimen of investigational 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.


Secondary Outcome Measures :
  1. Taste palatability of Zinc Dispersible Tablet [ Time Frame: 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. ]
    A subjective evaluation measured on the basis of a caregiver's report of his/her child's behavior (through a 5-point pictorial Hedonic scale) during the 10 days when the medicine is administered. A 'Diary Card' will be provided to the caregiver for keeping the daily records of the events.



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Ages Eligible for Study:   3 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039828


Contacts
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Contact: Azharul Islam Khan, PhD, MBBS +88-02-98271030 ext 2365 azharul@icddrb.org

Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Azharul Islam Khan, PhD, MBBS Chief Physician and Head, Hospitals, icddr,b

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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT04039828     History of Changes
Other Study ID Numbers: PR-19033
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Diarrhea
3 to 59 months children
Zinc tablet
acceptability
adherence
palatability
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents