Appetite DisordersPhase 4NCT03098810
Effect of Zinc Supplementation on Appetite and Growth in Primary Malnourished Children
A Phase 4 study testing Zinc sulphate in people with Appetite Disorders, run by Ain Shams University.
Trial summary
Zinc supplementation effect on appetite and growth of malnourished children Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite Disorders
- What is being tested?
- Zinc sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2017to 1 Dec 2017
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- primary malnourished
Who cannot join
- zinc supplementation in the previous 3 months Children with chronic disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Zinc Supplementation on Appetite and Growth of Primary Malnourished Children
Zinc supplementation effect on appetite and growth of malnourished children
Read the detailed description
The investigators will do s. Zinc and letting before and after zinc supplementation
- Conditions
- Appetite Disorders
- Being tested
- Zinc sulphate, Placebo
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc sulphateDrug
Oral syrup zinc sulphate
PlaceboOther
Oral syrup placebo
| Study group | Role | What they receive |
|---|---|---|
| Normal children | Placebo comparator | Placebo Receives: Other: Placebo |
| Malnourished children | Experimental | Oral zinc sulphate syrup Receives: Drug: Zinc sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite
Child eating behavior questionnaire
Measured: From start of supplementation to the end of the three months of supplementation
Secondary outcomes (2)
Weight
Weight
Measured: From start of supplementation to the end of the three months of supplementation
Height
Height
Measured: From start of supplementation to the end of the three months of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Apr 2017 (estimated)
- Primary completion1 Sep 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appetite DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marian girgis, Ain Shams University
- Investigators
- Marian Girgis, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098810
- Sponsor's protocol ID
- 2272009
- Status last verified
- Mar 2017
- First submitted
- 2 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.
PubMed 36994923
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zinc Supplementation on Appetite and Growth of Primary Malnourished Children
- ClinicalTrials.gov ID
- NCT03098810
- Acronym / sponsor ID
- 2272009
- Conditions
- Appetite Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 4 Apr 2017 (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 supplementation effect on appetite and growth of malnourished children
Detailed description
The investigators will do s. Zinc and letting before and after zinc supplementation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal children | Placebo comparator | Other: PlaceboPlacebo |
| Malnourished children | Experimental | Drug: Zinc sulphateOral zinc sulphate syrup |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- primary malnourished
Key exclusion criteria (1 listed)
- zinc supplementation in the previous 3 months Children with chronic 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 |
|---|---|---|
| Zinc sulphateOral syrup zinc sulphate | Drug | Malnourished children |
| PlaceboOral syrup placebo | Other | Normal children |
Primary outcome
Appetite
Time frame: From start of supplementation to the end of the three months of supplementation
Child eating behavior questionnaire
2 secondary outcomes
Weight
Time frame: From start of supplementation to the end of the three months of supplementation
Height
Time frame: From start of supplementation to the end of the three months of supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Derived from this study: PubMed 36994923Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.
- Individual participant dataSharing planned: No
Related trials for Appetite Disorders
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
RecruitingObservational study
An Open Label Pilot Study Assessing the Impact of Chromium Picolinate Supplementation on Appetite and Cravings in Overweight Individuals
Overweight (BMI > 25), Appetite
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
Recruiting
A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia
Schizophrenia, Antipsychotic Induced Weight Gain
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.
Marian Girgis principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zinc sulphate in people with Appetite Disorders, run by Ain Shams University.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marian Girgis (0201223646224, mariangirgis2009@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite (time frame: From start of supplementation to the end of the three months of supplementation). 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 NCT03098810, which also lists 1 linked publication.
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 4 Apr 2017.