Clinical trial NCT02542865: A Study to Investigate the Impact of Fortified Malt Based on Immunity Outcomes in School Children
Official title: Clinical Study to Measure the Impact of Fortified Malt Based Food on Immunity Outcomes in School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Development
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 924
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test the hypothesis that a fortified malt based food may improve immunity outcomes in 7-10 year old school age children.

Detailed description: This will be a single centre, multiple sites, open label, two-arm, parallel-group, stratified by gender, matched pair cluster randomised, controlled study in children aged 7-10 years.

Eligibility 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.

Primary outcomes:
measure: Total Number of Ill Days Due to Gastrointestinal (GI) and Respiratory Illness at Month 9
timeFrame: At month 9
Secondary outcomes:
measure: Frequency of GI and Respiratory Illnesses at Month 9
timeFrame: At month 9
measure: Severity of GI Illnesses at Month 9
timeFrame: At month 9
measure: Severity of Respiratory Illnesses at Month 9
timeFrame: At month 9
measure: School Absenteeism Assessment Due to GI and Respiratory Illnesses at Month 9
timeFrame: At month 9
measure: Change From Baseline in Body Mass Index (BMI) at Month 9
timeFrame: At screening and month 9
measure: Change From Baseline in Gut Integrity/ Health Measured by Urine Lactulose: Mannitol Test at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Gut Integrity/ Health Using Urinary Neopterin Assessment at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Mucosal Immunity Using Salivary Immunoglobulin A (IgA) Assessment at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Serum Levels of Trace Element Selenium (Se) at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Serum Levels of Micronutrient Vitamin B12 at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Serum Levels of Micronutrients Vitamin-D and Serum Folate at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Serum Levels of Micronutrient Vitamin-E at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Serum Levels of Ferritin Using Blood Testing at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Levels of Serum Transferrin Receptor (sTfR) Using Blood Testing at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Serum Levels of C-reactive Protein (CRP) and Alpha 1-acid Glycoprotein (AGP) Using Blood Testing at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Individual Dietary Diversity Score (IDDS) at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9
timeFrame: At baseline and month 9
measure: Change From Baseline in Energy Consumption at Month 9
timeFrame: At baseline and month 9
Other outcomes:
Locations:
city: Pune
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: