Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04039828
Other study ID # PR-19033
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2019
Est. completion date September 30, 2020

Study information

Verified date July 2019
Source International Centre for Diarrhoeal Disease Research, Bangladesh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Bangladesh Dhaka Hospital Dhaka
Bangladesh International centre for Diarrhoeal Disease Research, Bangladesh Dhaka

Sponsors (1)

Lead Sponsor Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Taste palatability of Zinc Dispersible Tablet 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. 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.
See also
  Status Clinical Trial Phase
Completed NCT03943654 - Improving Nighttime Access to Care and Treatment (Part 2)
Completed NCT01577043 - Efficacy of Racecadotril in Acute Watery Diarrhea in Children Phase 4
Not yet recruiting NCT03598010 - Safety, Tolerability and Preliminary Efficacy of Lenodiar Pediatric in Diarrhea N/A
Completed NCT03684538 - Efficacy Of Probiotics vs. Zinc vs. Probiotics-Zinc Combination On Acute Diarrhea In Children N/A
Terminated NCT02817165 - Probiotics for the Prevention of Antibiotic-Associated Diarrhea N/A
Completed NCT04237181 - Results of FilmArray® Gastro-intestinal Panel and Serum Procalcitonin in Acute Colitis and Infectious Diarrhea in the ER N/A
Completed NCT05345028 - Boswellia Serrata Extract in Acute Diarrhea N/A
Completed NCT01814202 - Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea N/A
Completed NCT02896465 - Human Milk Oligosaccharides and Childhood Diarrhoea N/A
Completed NCT01927094 - Effects of Probiotics and/or Prebiotics on the Duration of Diarrhea and Hospitalization in Children Phase 4
Completed NCT04796480 - Comparison Of Outcome Of Lactose Free Formula Milk With Yogurt In Children With Acute Diarrhea N/A
Completed NCT01571856 - Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Phase 4
Completed NCT01269892 - Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea Phase 2
Completed NCT00429325 - Fecal Calprotectin: Cheap Marker for Diagnosing Acute Infectious Diarrhea N/A
Recruiting NCT05183789 - IL6&8 in Malnourished Children With Acute Diarrhea
Completed NCT01564290 - Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children Phase 4
Recruiting NCT05213325 - Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroenteritis
Unknown status NCT01273012 - Cost-effectiveness of Infloran (TM) in Treating Acute Childhood Diarrhea in Phramongkutklao Hospital N/A
Completed NCT03356327 - Oral Administration of Tannins and Flavonoids in Children With Acute Diarrhea Phase 4