Last updated: 07/18/2020 12:11:47
A Study to investigate the impact of fortified malt based on immunity outcomes in school children
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical study to measure the impact of fortified malt based food on immunity outcomes in school children
Trial description: This study will test the hypothesis that a fortified malt based food may improve immunity outcomes in 7-10 year old school age children.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of ill days
Timeframe: Baseline to 9 months
Secondary outcomes:
Frequency of GI and respiratory illnesses
Timeframe: Baseline to 9 months
Severity of GI illnesses
Timeframe: Baseline to 9 months
Severity of respiratory illnesses
Timeframe: Baseline to 9 months
School absenteeism assessment
Timeframe: Baseline to 9 months
Change from baseline in Body Mass Index (BMI)
Timeframe: Baseline to 9 months
Change from baseline in gut integrity/health as measured by Lactulose Mannitol test
Timeframe: Baseline to 9 months
Change from baseline in gut integrity/health as measured by Urinary Neopterin test
Timeframe: Baseline to 9 months
Change from baseline in mucosal immunity
Timeframe: Baseline to 9 months
Change from baseline in nutrient biochemistry
Timeframe: Baseline to 9 months
Change from baseline in ferritin, serum transferrin receptor, C-reactive protein and Alpha 1-acid glycoprotein levels
Timeframe: Baseline to 9 months
Change from baseline in Dietary Diversity Score
Timeframe: Baseline to 9 months
Change from baseline in macronutrients
Timeframe: Baseline to 9 months
Interventions:
Dietary supplement: Fortified malt based food
Enrollment:
924
Observational study model:
Not applicable
Primary completion date:
2018-06-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Growth and Development
Product
GSK3129091
Collaborators
Not applicable
Study date(s)
July 2017 to July 2018
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
7 - 10 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study and willingness to participate as evidenced by the parent’s and/or LAR’s voluntary written informed consent as well as written assent by the child and has received a signed and dated copyof the informed consent form as well as the assent form.
- Boys and girls aged between 7-10 years
- Children in Care (CiC): A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study and willingness to participate as evidenced by the parent’s and/or LAR’s voluntary written informed consent as well as written assent by the child and has received a signed and dated copyof the informed consent form as well as the assent form.
- Boys and girls aged between 7-10 years
- Child and parent/LAR understand and are willing, able and likely to comply with all study procedures and restrictions.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon physical examination and absence of any condition that could affect the child’s safety or wellbeing or their ability to understand and follow study procedures and requirements.
- Participants with HAZ of ≥-3 to ≤-1.
Exclusion criteria:
- Children in Care (CiC): A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Indication that child is likely to move out of geographical range of the study within the period of study intervention and activities, thus hindering the child’s compliance to study activities.
- Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit, participation in any nutritional study or didactic nutrition education in the last 6 months of the screening visit and previous participation in this study.
- Child with severe anaemia (Hemoglobin <8g/dL).
- Children with history of use of immunosuppressive therapy e.g. oral corticosteroids or chemotherapy in past six months prior to the screening visit.
- Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the test product or procedures, on the discretion of study physician.
- Recent history [2 months] of serious infections, injuries and/ or surgeries in the opinion of the investigator.
- Children consuming nutritional supplements and/or health food drinks on a regular basis (≥3 times a week) in last 3 months.
- Child belonging to an employee of the sponsor or the study site or members of their immediate family or sibling of a child already enrolled in the study.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2018-06-07
Actual study completion date
2018-06-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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