A Study to Investigate the Impact of Fortified Malt Based on Immunity Outcomes in School Children

GlaxoSmithKline924 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

924

Conditions

Growth and Development

Interventions

Fortified malt based foodDIETARY_SUPPLEMENT

Fortified malt based food

Eligibility

Sex: ALLMin age: 7 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Pune, India

Outcomes

Primary Outcomes

Total Number of Ill Days Due to Gastrointestinal (GI) and Respiratory Illness at Month 9

Number of days a participant was ill due to GI and/or respiratory illness as diagnosed by physician, as per criteria defined, over the intervention duration. This equals total number of days (symptomatic or asymptomatic) in illnesses episodes whereas each episode is defined as an incidence of illness followed by at least 3 symptoms free days. GI illness was defined as an acute illness that includes any of following symptoms:3 or more loose/liquid/watery stools and/or vomiting in 24hours (h). Respiratory illness was defined as an acute illness that included more than or equal to \[\>=\] 1 of the following symptoms: runny nose, stuffy or blocked nose, cough fever or chills, sore throat or sneezing.

Time frame: At month 9

Secondary Outcomes

Frequency of GI and Respiratory Illnesses at Month 9

Number of episodes of GI and respiratory illnesses was calculated at month 9 using a diagnosis form (DF) which were used to note the diagnosis, severity, and school absenteeism due to GI and respiratory illnesses only, as defined in the study protocol. The DF captured the start and end date of all occurrences of GI and respiratory illnesses in the week. The frequency was calculated as total number of GI and respiratory illness episodes, divided by duration of intervention, where each episode is defined as each incidence of illness followed by at least uninterrupted 3 symptom free days. Therefore, the formula for calculation used was: frequency (per month) = number of episodes multiply (x) 30 and divided by (/) number of days between first and last visit.

Time frame: At month 9

Severity of GI Illnesses at Month 9

Severity of GI illness was calculated at month 9 using DF with observations listed by study physician based on assessment of severity grade: classified as, diarrhea (Mild, increase of less than \[\<\] 4 stools per \[/\] day over baseline; Moderate, increase of 4 to 6 stools/day over baseline; Severe, increase of more than or equal to \[\>=\]7 loose stools/day over baseline) and vomiting (1-2 episodes, separated by 5 minutes\[min\] in 24 h; Moderate, 3-5 episodes, separated by 5 min in 24 h; Severe, \>=6 episodes, separated by 5 min in 24 h. The count of participants was calculated based on the episode of worst severity. Lower severity indicates no illness of participant.

Data from ClinicalTrials.gov

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Time frame: At month 9

Severity of Respiratory Illnesses at Month 9

Intensity of respiratory illness was calculated at month 9 using DF with observations listed by study physician based on assessment of severity grade classified as, Mild or Grade1 is asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Moderate or Grade 2 is minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Instrumental ADL refer to school attendance, playing, studying, participating in school activities; and Severe or Grade 3 and 4: Grade 3 is severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Self-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden; Grade 4 is life-threatening consequences; urgent indication indicated.

Time frame: At month 9

School Absenteeism Assessment Due to GI and Respiratory Illnesses at Month 9

School absenteeism was calculated as number of days when a participant failed to attend school because of GI and/or respiratory illnesses. DF was used to note school absenteeism , however it was marked for absenteeism due to GI and respiratory illnesses only.

Time frame: At month 9

Change From Baseline in Body Mass Index (BMI) at Month 9

Change in Body Mass Index (BMI) was calculated at month 9 using anthropometric measurements. For measuring participant's height, portable stadio-meter was used with the participant standing barefoot; to the nearest 0.1 centimeters (cm) and average of 3 measurements were recorded. All data recorded in cm were converted to meters (m) for BMI calculation. For measuring participant's weight, standardized weighing scale was used in standard clothing to the nearest 0.1kilograms (kg) and average of 3 measurements were recorded. BMI value was calculated using the formula weight divided by square of height (weight \[kilogram (kg)/ Height \[meter (m)\]\^2)

Time frame: At screening and month 9

Change From Baseline in Gut Integrity/ Health Measured by Urine Lactulose: Mannitol Test at Month 9

Improvement in gut wall integrity was considered a possible factor to assess the micronutrient absorption. Lactulose mannitol test was used to evaluate change in gut wall permeability status to assess impact on micronutrient absorption. After 3h of fasting, pre-measured amount of lactulose/mannitol solution (2 milliliter/Kilogram \[mL/Kg\] of body weight) containing lactulose (250 milligram/milliliter \[mg/mL\])\] and mannitol (50 mg/mL) was administered as a test solution. Participants were allowed to return to their regular diet 30 minutes after ingestion of the test solution. During the 2.5 h time, participants were offered liquids frequently in order to permit collection of an adequate volume of urine. After 2.5 h, urine collection was performed. All urine passed over duration of 2.5 h was collected and analysed. High Performance Liquid Chromatography (HPLC) test method was used to measure the levels. The normal range of urinary lactulose: mannitol is less than \[\<\] 0.035.