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
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh