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| ID | Type | Description | Link |
|---|---|---|---|
| RH01722 | Other Identifier | GSK |
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The effect of supplementation using both protein and multiple micronutrients in preschool age children on cognitive performance and growth is unknown. The study will compare the effect of combination of protein and multiple micronutrients on indicators of cognitive performance and growth in preschool age children. Cognitive performance and anthropometric assessments will be measured at baseline and at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test beverage powder | Experimental | 30 grams of cereal beverage powder with protein and added micronutrients will be made up to 100 mL drink using luke warm water. Subjects will be administered two doses of the drink (100 mL each) everyday |
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| Control beverage powder | Active Comparator | 30 grams of cereal beverage powder with low protein and no added micronutrients will be made up to 100 mL using luke warm water. Subjects will be administered two doses of the drink (100 mL each) everyday |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test beverage powder (High Proteins and added micronutrients) | Other | High protein and added Micronutrients at recommended dietary allowance levels |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Short Term Memory at 6 Months | Short term memory was measured using word order and number recall sub tests of Kaufman Assessment Battery for Children (KABC).In Number Recall, child was asked to repeat series of number in same sequence after making sure that child is paying attention.A score of 0 and 1 given for incorrect and correct response respectively. In Word Order,qualified site staff said series of words and child then pointed pictures of those words in same sequence.Later items (object cards with pictures) included an interference task in which child named colors after hearing the word. Each subtest score was the total of item scores, ranging from 0-31 for word order and 0-22 for number recall. The two subtest scores were standardized for each subject and visit (Z score), and short term memory was calculated as the average of the two standardized values where higher scores reflect better short term memory. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weight at 6 Months | Weight was measured (single measurement) in standard clothing on weighing scale to the nearest 0.1kilograms(kg). | Baseline and 6 months |
| Change From Baseline in Height at 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Karamsad | Gujarat | 388325 | India |
A total of 656 participants were screened out of which 528 were randomized to study treatments. 363 participants completed the study. Of the 165 randomized participants not completing the study, 152 withdrew consent, 10 participants violated the protocol, 2 participants were lost to follow up and 1 withdrew due to adverse event.
Participants were recruited at one center in India.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test | 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mililiters (mL) drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Control beverage powder (Low protein and no added micronutrients) | Other | Low protein and no added micronutrients |
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Height was measured (single measurement) using a portable stadio-meter, with the participant standing bare-foot, to the nearest 0.1centimeters (cm).
| Baseline and 6 months |
| Change From Baseline in Body Mass Index (BMI) at 6 Months | BMI for was obtained using the World Health Organization Anthroplus software version 1.0.2. | Baseline and 6 months |
| Change From Baseline in Triceps Skin Fold (TSF) at 6 Months | The TSF was measured in the midline of the posterior aspect of the arm, over the triceps muscle, at a level midway between the lateral projection of the acromion process of the scapula and the inferior margin of the olecranon process of the ulna. The right elbow is flexed at 90°and the midpoint between the acromion and the olecranon process is located and marked at the lateral side of the arm. The skinfold was then measured with the arm hanging loosely while standing. The triceps skinfold was picked up with the left thumb and index finger approximately 1cm proximal to the marked level and the tips calipers were applied to the skin-fold at the marked level. The triceps measurement was done (three measurements) using Holtain calipers to the nearest 0.2 millimeters (mm) and the average value was recorded. | Baseline and 6 months |
| Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months | The MUAC (single measurement) was measured midway between the acromion and the olecranon process, while the participant stands with the elbow flexed at 90. The circumference was measured with a fiber glass tape to the nearest 0.1 cm on the right hand. | Baseline and 6 months |
| Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months | Using the MUAC measurement and TSF measurement, the arm muscle AMA and AFA were calculated i.e. AMA (cm2) = (MUAC-(π*TSF))2/4 π and AFA (cm2) = (MUAC2/4π) - AMA | Baseline and 6 months |
| Number of Ill Days at 6 Months | Number of ill days due to cold, cough and/or associated fever were recorded. The mean number of ill days due was analyzed at 6 months using Analysis of Variance (ANOVA). | Baseline upto 6 months |
| Change From Baseline in Problem Solving at 6 Months | Test measured visual construction ability, understanding of spatial relationships and problem solving abilities. The child arranged flat shapes of various sizes and colors (items) to match a model or picture as instructed by the qualified staff. For items 1 to 2 (score 2 for success on first trial and 1 on second trial); items 3 to 10 (Score 1 for success and 0 for failure on first trial). The test continued till 3 consecutive scores of 0. The Raw score was the total of item score. Score range 0-29. Higher scores reflect better short term memory | Baseline and 6 months |
30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday. |
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| NOT COMPLETED |
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ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population. ITT (N=363)
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| ID | Title | Description |
|---|---|---|
| BG000 | Test | 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday. |
| BG001 | Control | 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Short Term Memory at 6 Months | Short term memory was measured using word order and number recall sub tests of Kaufman Assessment Battery for Children (KABC).In Number Recall, child was asked to repeat series of number in same sequence after making sure that child is paying attention.A score of 0 and 1 given for incorrect and correct response respectively. In Word Order,qualified site staff said series of words and child then pointed pictures of those words in same sequence.Later items (object cards with pictures) included an interference task in which child named colors after hearing the word. Each subtest score was the total of item scores, ranging from 0-31 for word order and 0-22 for number recall. The two subtest scores were standardized for each subject and visit (Z score), and short term memory was calculated as the average of the two standardized values where higher scores reflect better short term memory. | ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6 months |
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| Secondary | Change From Baseline in Weight at 6 Months | Weight was measured (single measurement) in standard clothing on weighing scale to the nearest 0.1kilograms(kg). | ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | kg | Baseline and 6 months |
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| Secondary | Change From Baseline in Height at 6 Months | Height was measured (single measurement) using a portable stadio-meter, with the participant standing bare-foot, to the nearest 0.1centimeters (cm). | ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | cm | Baseline and 6 months |
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| Secondary | Change From Baseline in Body Mass Index (BMI) at 6 Months | BMI for was obtained using the World Health Organization Anthroplus software version 1.0.2. | ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline and 6 months |
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| Secondary | Change From Baseline in Triceps Skin Fold (TSF) at 6 Months | The TSF was measured in the midline of the posterior aspect of the arm, over the triceps muscle, at a level midway between the lateral projection of the acromion process of the scapula and the inferior margin of the olecranon process of the ulna. The right elbow is flexed at 90°and the midpoint between the acromion and the olecranon process is located and marked at the lateral side of the arm. The skinfold was then measured with the arm hanging loosely while standing. The triceps skinfold was picked up with the left thumb and index finger approximately 1cm proximal to the marked level and the tips calipers were applied to the skin-fold at the marked level. The triceps measurement was done (three measurements) using Holtain calipers to the nearest 0.2 millimeters (mm) and the average value was recorded. | ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | mm | Baseline and 6 months |
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| Secondary | Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months | The MUAC (single measurement) was measured midway between the acromion and the olecranon process, while the participant stands with the elbow flexed at 90. The circumference was measured with a fiber glass tape to the nearest 0.1 cm on the right hand. | ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | cm | Baseline and 6 months |
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| Secondary | Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months | Using the MUAC measurement and TSF measurement, the arm muscle AMA and AFA were calculated i.e. AMA (cm2) = (MUAC-(π*TSF))2/4 π and AFA (cm2) = (MUAC2/4π) - AMA | ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | Centimeter square Cm^2 | Baseline and 6 months |
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| Secondary | Number of Ill Days at 6 Months | Number of ill days due to cold, cough and/or associated fever were recorded. The mean number of ill days due was analyzed at 6 months using Analysis of Variance (ANOVA). | ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | Number of days | Baseline upto 6 months |
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| Secondary | Change From Baseline in Problem Solving at 6 Months | Test measured visual construction ability, understanding of spatial relationships and problem solving abilities. The child arranged flat shapes of various sizes and colors (items) to match a model or picture as instructed by the qualified staff. For items 1 to 2 (score 2 for success on first trial and 1 on second trial); items 3 to 10 (Score 1 for success and 0 for failure on first trial). The test continued till 3 consecutive scores of 0. The Raw score was the total of item score. Score range 0-29. Higher scores reflect better short term memory | ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6 months |
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Safety population, defined as all participants who were randomized and administered at least one study treatment during the study. The population of analysis was safety population (N=524).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test | 30 grams of cereal beverage powder with protein and added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday. | 0 | 259 | 30 | 259 | ||
| EG001 | Control | 30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday. | 3 | 265 | 33 | 265 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONVULSION | Nervous system disorders | Systematic Assessment |
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| STATUS EPILAPTICUS | Nervous system disorders | Systematic Assessment |
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| ACUTE GASTRO ENTERITIS | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Systematic Assessment |
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| PYODERMA | Infections and infestations | Systematic Assessment |
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| VARICELLA | Infections and infestations | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | Systematic Assessment |
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| IMPETIGO | Infections and infestations | Systematic Assessment |
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| TYPHOID FEVER | Infections and infestations | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | Systematic Assessment |
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| NAUSEA | Infections and infestations | Systematic Assessment |
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| PYREXIA | General disorders | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D018753 | Diet, Protein-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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30 grams of cereal beverage powder with low protein and no added micronutrients was made up to 100 mL drink using luke warm water. Participants were administered two doses of the drink (100 mL each) everyday.
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