A Study to investigate the impact of fortified malt based on immunity outcomes in school children.
- Registration Number
- CTRI/2017/07/008979
- Lead Sponsor
- GlaxoSmithKline Consumer Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
1.Demonstrates understanding of the study and willingness to participate as evidenced by the parentâ??s and/or LARâ??s voluntary written informed consent as well as written assent by the child and has received a signed and dated copy of the informed consent form as well as the assent form.
2.Boys and girls aged between 7-10 years
3.Child and parent/LAR understand and are willing, able and likely to comply with all study procedures and restrictions.
4.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 childâ??s safety or wellbeing or their ability to understand and follow study procedures and requirements.
5.Participants with HAZ of >=-3 to <=-1.
1.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.
2.Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
3.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 childâ??s compliance to study activities.
4.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.
5.Child with severe anaemia (Hemoglobin <8g/dL).
6.Children with history of use of immunosuppressive therapy e.g. oral corticosteroids or chemotherapy in past six months prior to the screening visit.
7.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.
8.Recent history [2 months] of serious infections, injuries and/ or surgeries in the opinion of the investigator.
9.Children consuming nutritional supplements and/or health food drinks on a regular basis (>=3 times a week) in last 3 months.
10.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of ill daysTimepoint: Baseline to 9 months
- Secondary Outcome Measures
Name Time Method Change from baseline in Body Mass Index (BMI)Timepoint: Baseline to 9 months;Change from baseline in Dietary Diversity ScoreTimepoint: Baseline to 9 months;Change from baseline in ferritin, serum transferrin receptor, C-reactive protein and Alpha 1-acid glycoprotein levelsTimepoint: Baseline to 9 months;Change from baseline in gut integrity/health as measured by Lactulose Mannitol testTimepoint: Baseline to 9 months;Change from baseline in gut <br/ ><br>integrity/health as measured by Urinary Neopterin testTimepoint: Baseline to 9 months;Change from baseline in macronutrientsTimepoint: Baseline to 9 months;Change from baseline in mucosal immunityTimepoint: Baseline to 9 months;Change from baseline in nutrient biochemistryTimepoint: Baseline to 9 months;Frequency of GI and respiratory illnessesTimepoint: Baseline to 9 months;School absenteesm due to GI and respiratory illnessesTimepoint: Baseline to 9 months;Severity of GI and respiratory illnessesTimepoint: Baseline to 9 months