Primary MalnurtritionPhase 4NCT03040219
Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children
A Phase 4 study testing Folic Acid in people with Primary Malnurtrition, run by Ain Shams University at 1 site in Egypt.
Trial summary
Folic acid as a appetizer in primary malnutrition Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Malnurtrition
- What is being tested?
- Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary malnourished children
Who cannot join
- previous folic supplementation in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Folic acid as a appetizer in primary malnutrition
- Conditions
- Primary Malnurtrition
- Being tested
- Folic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic AcidDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Not described Receives: Drug: Folic Acid |
| Control | Placebo comparator | Not described Receives: Drug: Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite
Child eating behaviour questionnaire
Measured: Through study completion_ after 3 months from start of supplementation
Secondary outcomes (1)
Leptin and ghrelin hormone
Serum level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Apr 2017 (estimated)
- Primary completion1 Nov 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.
- Other trials for Primary MalnurtritionStudies 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
- None (open label)
- Enrolment
- 100 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
- NCT03040219
- Sponsor's protocol ID
- 27111982
- Status last verified
- Mar 2017
- First submitted
- 20 Jan 2017
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folic Acid Supplementation as an Appetizer in Primary Malnourished Egyptian Infants and Children
- ClinicalTrials.gov ID
- NCT03040219
- Acronym / sponsor ID
- 27111982
- Conditions
- Primary Malnurtrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- 1 Nov 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 2 Feb 2017 (estimated)
- 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.
Folic acid as a appetizer in primary malnutrition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: Folic Acid |
| Control | Placebo comparator | Drug: Folic Acid |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Primary malnourished children
Key exclusion criteria (1 listed)
- previous folic supplementation in the past 3 months
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 |
|---|---|---|
| Folic AcidTablets | Drug | Control, Treatment group |
Primary outcome
Appetite
Time frame: Through study completion_ after 3 months from start of supplementation
Child eating behaviour questionnaire
1 secondary outcome
Leptin and ghrelin hormone
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: Undecided
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
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 Folic Acid in people with Primary Malnurtrition, 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 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 14 Mar 2017. 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?
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: Through study completion_ after 3 months from start of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2017.