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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02177942 |
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Date of registration:
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26/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Clinical Trial to Study the Impact of a Nutritional Beverage on Tests of Memory in Healthy Preschool Age Children
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Scientific title:
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A Double Blind Randomised Controlled Trial in Pre-school Age Children to Evaluate the Impact of a Nutritional Beverage Powder on Cognitive Performance Measures |
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Date of first enrolment:
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June 20, 2014 |
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Target sample size:
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528 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02177942 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Consent: Demonstrates understanding of the study and willingness to participate as
evidenced by subject's parents or legally authorised representative's voluntary
written informed consent and has received a signed and dated copy of the informed
consent form.
2. Compliance : Understands and is willing, able and likely to comply with all study
procedures and restrictions
3. General Health : Good general and mental health with, in the opinion of the
investigator
4. Child with BMI for age between <+1 standard deviation (SD) to > -2SD
Exclusion Criteria:
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.
2. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study
materials (lactose, wheat gluten, soy protein) or any of their stated ingredients.
3. Child with severe anaemia (Haemoglobin < 7 g/dl) as determined by the non invasive
spectrophotometry results.
4. Participation in another clinical study or receipt of an investigational drug within
30 days of the screening visit.
5. Participation in any nutritional study or didactic nutrition education in the last 6
months of the screening visit
5. Current or relevant history of any serious, severe or unstable physical or psychiatric
illness or any medical disorder that would make the subject unlikely to fully complete the
study or any condition that presents undue risk from the study product or procedures in the
opinion of the investigator.
6. Recent history (3 months) of serious infections, injuries and/ or surgeries. 7. Children
consuming iron, calcium and/or other nutritional supplements and/ or health food drinks on
a regular basis (more than 3 times a week, in the recommended dosage) in the last 1 month
prior to screening visit.
8. Use of any prescription medications during the study period for more than or equal to
two weeks.
Age minimum:
36 Months
Age maximum:
65 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cognition
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Intervention(s)
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Other: Control beverage powder (Low protein and no added micronutrients)
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Other: Test beverage powder (High Proteins and added micronutrients)
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Primary Outcome(s)
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Change From Baseline in Short Term Memory at 6 Months
[Time Frame: Baseline and 6 months]
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Secondary Outcome(s)
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Change From Baseline in Height at 6 Months
[Time Frame: Baseline and 6 months]
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Change From Baseline in Triceps Skin Fold (TSF) at 6 Months
[Time Frame: Baseline and 6 months]
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Number of Ill Days at 6 Months
[Time Frame: Baseline upto 6 months]
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Change From Baseline in Problem Solving at 6 Months
[Time Frame: Baseline and 6 months]
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Change From Baseline in Weight at 6 Months
[Time Frame: Baseline and 6 months]
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Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months
[Time Frame: Baseline and 6 months]
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Change From Baseline in Body Mass Index (BMI) at 6 Months
[Time Frame: Baseline and 6 months]
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Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months
[Time Frame: Baseline and 6 months]
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Secondary ID(s)
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RH01722
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202155
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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