Zinc DeficiencyPhase 4RCTZNCT05002101
Daily Zinc Supplement Effect on Prevention of Diarrhea and Acute Respiratory Infections in Children Less Than Five Years
A Phase 4 study testing zinc in people with Zinc Deficiency and Child Nutrition Disorders, run by Ain Shams University at 1 site in Egypt.
Trial summary
Zinc deficiency in children is a major problem which leads to compromised immunity and accordingly repeated infections. This study aims to investigate the effect of supplementing zinc to decrease the incidence of diarrhea and respiratory illness in children between 6 months and 5 years in Paediatric Outpatient Clinic… Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency, Child Nutrition Disorders
- What is being tested?
- zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy child with good general health
Who cannot join
- Children with severe malnutrition requiring hospital admission,
- Cases of chronic and metabolic diseases as diabetic children
- Children suffering from any type of cancer or any other debilitating disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Daily Zinc Supplementation on Prevention of Diarrhea and Acute Respiratory Infections Among Children Less Than Five Years: A Randomized Controlled Trial
Zinc deficiency in children is a major problem which leads to compromised immunity and accordingly repeated infections. This study aims to investigate the effect of supplementing zinc to decrease the incidence of diarrhea and respiratory illness in children between 6 months and 5 years in Paediatric Outpatient Clinic in Ain Shams University Hospital.
Read the detailed description
Zinc is a trace element that plays essential roles in protein and lipid metabolism, cell growth and differentiation, and the immune system; either cellular or humoral immunity. There is no specialized zinc storage system in the body, accordingly, a daily intake of zinc is required to maintain a steady state. Zinc deficiency can cause compromised immune function, accordingly this can lead to infections and growth defects among young children According to literature review search, there is lack of studies on the preventive effect of zinc supplementation on Egyptian children less than five years old; the age group which is known by the suboptimal nutritional status and the high prevalence of infection. Accordingly, the present study is aiming to evaluate the impact of 4 months of daily zinc supplementation on the incidence of diarrhea and respiratory illness and to detect the frequency of daily dietary intake of zinc-rich food children between 6 months and 5 years in Paediatric Outpatient Clinic in Ain Shams University Hospital.
Objectives:
- To evaluate the impact of 4 months of daily zinc supplementation on:
- the incidence and the severity of diarrheal morbidity.
- the incidence of acute respiratory infection.
- To measure the level of serum zinc in children between 6 months and 5 years attending Paediatric Outpatient Clinic in Ain Shams University Hospital.
- To compare between children who had initially low serum zinc level with those with normal level as regard the reduction in the incidence of diarrhea and respiratory illness.
- To measure the frequency of daily dietary intake of zinc-rich food in children between 6 months and 5 years attending Paediatric Outpatient Clinic in Ain Shams University Hospital. Methodology:
- Study type: a single blinded, randomized controlled trial.
- Study setting: Paediatric Outpatient Clinic in Ain Shams University Hospital.
- Sampling method: A convenience sample of children between 6 months and 5 years was recruited from the Paediatric Outpatient Clinic in Ain Shams University Hospital.
- Study population: Eligible children aged between 6 months and 5 years attending Paediatric Outpatient Clinic in Ain Shams University Hospital was included. Randomization and allocation: Random assignment of the sampled children to either the study group receiving zinc or the control group receiving placebo was done. The study was single-blinded, where the children's mothers won't know either their children are enrolled in the study group or the control group.
- Study tool:
- Baseline questionnaire: Structured interview questionnaire was used at the first meeting with the mother to collect baseline data. The questionnaire includes baseline characteristics, such as child age, child sex, family size, child rank, child feeding practices (breastfeeding), maternal literacy, vaccination history and birth weight. Also, the baseline questionnaire assessed the occurrence and duration of diarrhea and respiratory illness in the past month before the start of zinc supplementation. Questions are adopted from the Demographic and Health Survey (DHS) questionnaire (Ministry of Health and Population/Egypt, 2015).
- Questionnaire for Zinc-Rich Food Intake Pattern: The questionnaire, a dietary history recall instrument, was used to elicit and capture information on frequency of daily dietary intake over previous 1 month of two categories of zinc-rich foods namely:
- Foods of animal origin devoid of zinc antinutritional factor (liver, fish, milk, eggs)
- Food of vegetable origin including those known to contain a zinc antinutritional factor (cereals, beans)
- Serum zinc: A blood sample was collected from all included children at the beginning of the study to estimate the baseline serum zinc level. Venous blood samples (about 4 milliliters) were collected in heparinised tubes and transported to the laboratory for centrifugation and serum zinc estimation using atomic absorption spectrophotometer graphites.
- Intervention: The children were randomized to receive daily zinc sulphate or placebo. The elemental zinc dose was 3 mg/ day to children whose weight is less than 10 kg and 7 mg/ day to children whose weight is 10 kg or more. This dose is more than the recommended dietary allowance for supplementation so as to allow for possible impairment in absorption of ingested zinc among children as a result of consumption of a predominantly phytate-rich cereal-based diet, bacterial overgrowth, and protozoal or parasitic infestations. At the same time the dose won't exceed the upper tolerable level for zinc (World Health Organization and Food and Agriculture Organization of the United Nations, 2005). One bottle that contained 150 mL was kept in the child's home and replaced monthly. The placebo was non-nutritious and vitamin-free, designed to be identical to the zinc syrup in colour, odour, and taste.
- Follow up: Each month, during the child visit to the Paediatric Outpatient Clinic, or through a telephone call, the mother was asked certain questions regarding the occurrence and duration of diarrhea and respiratory illness in the past month. Questions are adopted from the Demographic and Health Survey (DHS) questionnaire (Ministry of Health and Population/Egypt, 2015).
- Pre- and posttreatment anthropometric parameters (weight and length\ height measurements) were recorded. Nutritional status was assessed by measuring weight and height using standard methods and calculating weight for-age and weight-for-height Z scores. Weight was measured to nearest 100 gm using an electronic scale.
- Conditions
- Zinc Deficiency, Child Nutrition Disorders
- Being tested
- zinc, Placebo
- Keywords
- zinc, diarrhea, Respiratory Tract Infections, prevention
- Medical subject headings
- Child Nutrition Disorders, Diarrhea, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zincDietary supplement
Also called zinc sulphate
The zinc syrup was prepared with a concentration of 7 mg zinc in each 5 ml solution. Accordingly, children with weight more than 10 kg were asked to take 5 ml syrup daily, while children with weight less than 10 kg were asked to take 2.5 ml daily.
PlaceboDrug
Also called inactive substance
Children with weight more than 10 kg were asked to take 5 ml syrup daily, while children with weight less than 10 kg were asked to take 2.5 ml daily.
| Study group | Role | What they receive |
|---|---|---|
| zinc group | Active comparator | The children were randomized to receive daily zinc sulphate. The elemental zinc dose was 3 mg/ day to children whose weight is less than 10 kg and 7 mg/ day to children whose weight is 10 kg or more. Receives: Dietary Supplement: zinc |
| placebo group | Placebo comparator | The placebo was non-nutritious and vitamin-free, designed to be identical to the zinc syrup in colour, odour, consistency and taste. Zinc and placebo syrups were packaged in similar bottles. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the baseline cumulative incidence rate of diarrhea at 4 months
Cumulative incidence rate of diarrhea at the baseline before intervention was compared to the cumulative incidence rate of diarrhea after 4 months of daily zinc supplements administration
Measured: after 4 months
Change in the baseline cumulative incidence rate of acute respiratory infections at 4 months
Cumulative incidence rate of acute respiratory infections at the baseline before intervention was compared to the cumulative incidence rate of acute respiratory infections after 4 months of daily zinc supplements administration.
Measured: after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Aug 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Zinc DeficiencyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yosra Samir Abd El Ghaffar Souliman, Ain Shams University
- Investigators
- Ahmed E Shouman, Professor, Study director, Faculty of Medicine, Ain-Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002101
- Sponsor's protocol ID
- MD180 2018
- Acronym
- RCTZ
- Status last verified
- Aug 2021
- First submitted
- 26 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liberato SC, Singh G, Mulholland K. Zinc supplementation in young children: A review of the literature focusing on diarrhoea prevention and treatment. Clin Nutr. 2015 Apr;34(2):181-8. doi: 10.1016/j.clnu.2014.08.002. Epub 2014 Aug 13.
PubMed 25176404Abd El-Ghaffar YS, Shouman AE, Hakim SA, El Gendy YGA, Wahdan MMM. Effect of Zinc Supplementation in Children Less Than 5 Years on Diarrhea Attacks: A Randomized Controlled Trial. Glob Pediatr Health. 2022 Jun 17;9:2333794X221099266. doi: 10.1177/2333794X221099266. eCollection 2022.
PubMed 35747897
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Zinc Supplementation on Prevention of Diarrhea and Acute Respiratory Infections Among Children Less Than Five Years: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05002101
- Acronym / sponsor ID
- RCTZ / MD180 2018
- Conditions
- Zinc Deficiency, Child Nutrition Disorders
- Keywords
- zinc, diarrhea, Respiratory Tract Infections, prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Zinc deficiency in children is a major problem which leads to compromised immunity and accordingly repeated infections. This study aims to investigate the effect of supplementing zinc to decrease the incidence of diarrhea and respiratory illness in children between 6 months and 5 years in Paediatric Outpatient Clinic in Ain Shams University Hospital.
Detailed description
Zinc is a trace element that plays essential roles in protein and lipid metabolism, cell growth and differentiation, and the immune system; either cellular or humoral immunity. There is no specialized zinc storage system in the body, accordingly, a daily intake of zinc is required to maintain a steady state. Zinc deficiency can cause compromised immune function, accordingly this can lead to infections and growth defects among young children According to literature review search, there is lack of studies on the preventive effect of zinc supplementation on Egyptian children less than five years old; the age group which is known by the suboptimal nutritional status and the high prevalence of infection. Accordingly, the present study is aiming to evaluate the impact of 4 months of daily zinc supplementation on the incidence of diarrhea and respiratory illness and to detect the frequency of daily dietary intake of zinc-rich food children between 6 months and 5 years in Paediatric Outpatient Clinic in Ain Shams University Hospital.
Objectives:
- To evaluate the impact of 4 months of daily zinc supplementation on:
- the incidence and the severity of diarrheal morbidity.
- the incidence of acute respiratory infection.
- To measure the level of serum zinc in children between 6 months and 5 years attending Paediatric Outpatient Clinic in Ain Shams University Hospital.
- To compare between children who had initially low serum zinc level with those with normal level as regard the reduction in the incidence of diarrhea and respiratory illness.
- To measure the frequency of daily dietary intake of zinc-rich food in children between 6 months and 5 years attending Paediatric Outpatient Clinic in Ain Shams University Hospital. Methodology:
- Study type: a single blinded, randomized controlled trial.
- Study setting: Paediatric Outpatient Clinic in Ain Shams University Hospital.
- Sampling method: A convenience sample of children between 6 months and 5 years was recruited from the Paediatric Outpatient Clinic in Ain Shams University Hospital.
- Study population: Eligible children aged between 6 months and 5 years attending Paediatric Outpatient Clinic in Ain Shams University Hospital was included. Randomization and allocation: Random assignment of the sampled children to either the study group receiving zinc or the control group receiving placebo was done. The study was single-blinded, where the children's mothers won't know either their children are enrolled in the study group or the control group.
- Study tool:
- Baseline questionnaire: Structured interview questionnaire was used at the first meeting with the mother to collect baseline data. The questionnaire includes baseline characteristics, such as child age, child sex, family size, child rank, child feeding practices (breastfeeding), maternal literacy, vaccination history and birth weight. Also, the baseline questionnaire assessed the occurrence and duration of diarrhea and respiratory illness in the past month before the start of zinc supplementation. Questions are adopted from the Demographic and Health Survey (DHS) questionnaire (Ministry of Health and Population/Egypt, 2015).
- Questionnaire for Zinc-Rich Food Intake Pattern: The questionnaire, a dietary history recall instrument, was used to elicit and capture information on frequency of daily dietary intake over previous 1 month of two categories of zinc-rich foods namely:
- Foods of animal origin devoid of zinc antinutritional factor (liver, fish, milk, eggs)
- Food of vegetable origin including those known to contain a zinc antinutritional factor (cereals, beans)
- Serum zinc: A blood sample was collected from all included children at the beginning of the study to estimate the baseline serum zinc level. Venous blood samples (about 4 milliliters) were collected in heparinised tubes and transported to the laboratory for centrifugation and serum zinc estimation using atomic absorption spectrophotometer graphites.
- Intervention: The children were randomized to receive daily zinc sulphate or placebo. The elemental zinc dose was 3 mg/ day to children whose weight is less than 10 kg and 7 mg/ day to children whose weight is 10 kg or more. This dose is more than the recommended dietary allowance for supplementation so as to allow for possible impairment in absorption of ingested zinc among children as a result of consumption of a predominantly phytate-rich cereal-based diet, bacterial overgrowth, and protozoal or parasitic infestations. At the same time the dose won't exceed the upper tolerable level for zinc (World Health Organization and Food and Agriculture Organization of the United Nations, 2005). One bottle that contained 150 mL was kept in the child's home and replaced monthly. The placebo was non-nutritious and vitamin-free, designed to be identical to the zinc syrup in colour, odour, and taste.
- Follow up: Each month, during the child visit to the Paediatric Outpatient Clinic, or through a telephone call, the mother was asked certain questions regarding the occurrence and duration of diarrhea and respiratory illness in the past month. Questions are adopted from the Demographic and Health Survey (DHS) questionnaire (Ministry of Health and Population/Egypt, 2015).
- Pre- and posttreatment anthropometric parameters (weight and length\ height measurements) were recorded. Nutritional status was assessed by measuring weight and height using standard methods and calculating weight for-age and weight-for-height Z scores. Weight was measured to nearest 100 gm using an electronic scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zinc group | Active comparator | Dietary Supplement: zincThe children were randomized to receive daily zinc sulphate. The elemental zinc dose was 3 mg/ day to children whose weight is less than 10 kg and 7 mg/ day to children whose weight is 10 kg or more. |
| placebo group | Placebo comparator | Drug: PlaceboThe placebo was non-nutritious and vitamin-free, designed to be identical to the zinc syrup in colour, odour, consistency and taste. Zinc and placebo syrups were packaged in similar bottles. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Apparently healthy child with good general health
Key exclusion criteria (3 listed)
- Children with severe malnutrition requiring hospital admission,
- Cases of chronic and metabolic diseases as diabetic children
- Children suffering from any type of cancer or any other debilitating disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zincAlso: zinc sulphateThe zinc syrup was prepared with a concentration of 7 mg zinc in each 5 ml solution. Accordingly, children with weight more than 10 kg were asked to take 5 ml syrup daily, while children with weight less than 10 kg were asked to take 2.5 ml daily. | Dietary supplement | zinc group |
| PlaceboAlso: inactive substanceChildren with weight more than 10 kg were asked to take 5 ml syrup daily, while children with weight less than 10 kg were asked to take 2.5 ml daily. | Drug | placebo group |
Primary outcome
Change in the baseline cumulative incidence rate of diarrhea at 4 months
Time frame: after 4 months
Cumulative incidence rate of diarrhea at the baseline before intervention was compared to the cumulative incidence rate of diarrhea after 4 months of daily zinc supplements administration
Change in the baseline cumulative incidence rate of acute respiratory infections at 4 months
Time frame: after 4 months
Cumulative incidence rate of acute respiratory infections at the baseline before intervention was compared to the cumulative incidence rate of acute respiratory infections after 4 months of daily zinc supplements administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Results publication: PubMed 25176404Liberato SC, Singh G, Mulholland K. Zinc supplementation in young children: A review of the literature focusing on diarrhoea prevention and treatment. Clin Nutr. 2015 Apr;34(2):181-8. doi: 10.1016/j.clnu.2014.08.002. Epub 2014 Aug 13.
- Derived from this study: PubMed 35747897Abd El-Ghaffar YS, Shouman AE, Hakim SA, El Gendy YGA, Wahdan MMM. Effect of Zinc Supplementation in Children Less Than 5 Years on Diarrhea Attacks: A Randomized Controlled Trial. Glob Pediatr Health. 2022 Jun 17;9:2333794X221099266. doi: 10.1177/2333794X221099266. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed E Shouman, Professor study director
Faculty of Medicine, Ain-Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zinc in people with Zinc Deficiency and Child Nutrition Disorders, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the baseline cumulative incidence rate of diarrhea at 4 months (time frame: after 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05002101, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.