An Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Pedia Power†of Essen Fooddies India Pvt. Ltd as a Nutritional Supplement in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Anthropometric Measurements: Improvement of 10% from baseline.
研究概览
简要总结
Study Design : Open Label, Prospective, Non-Randomised,Non-Comparative, Single Arm Clinical Study
Indication : Nutritional Supplement for Clinically healthy Children
Investigational Product Details Name : PEDIA POWER Route of Administration : Oral Formulation : Powdered Nutritional Formulation Dose : 50g (5 scoops) in 150ml luke warm water Dosage : OD for 3 months
Subject Population : linically healthy children between the ages of 5 and14 years (both ages and all genders inclusive).
Treatment Arms : One. Non Comparative Single ArmStudy
Number of Subjects : 50 Subjects
Efficacy Assessments: 1. Anthropometric Measurements : Day 1, Day 45, Day 90 2. Fluency Test : Day 1, Day 45 Day 90 3. General Appetite : Day 1, Day 45, Day 90 4. IP Feedback Questionnaire : Day 90
Safety Assessments: 1. Clinical Safety : CBC, Serum Biochemistry 2. Monitoring of Adverse Events
Background of the study: Adietary supplement provides nutrients either extracted from food sources orthat are synthetic in order to increase the quantity of their consumption. Theclass of nutrient compounds includes vitamins, minerals, fiber, fatty acids andamino acids. Childhood and adolescenceare periods of continuous growth and development. To tackle this and to retainthe balanced nutritional status for the normal growth and development ofchildren, nutritional supplements are widely used. As children grow, it’simportant for them to get enough vitamins and minerals to ensure optimal healthand also it’s vital to get adequate amounts of nutrients that help them buildstrong bones, such as calcium and vitamin D. Moreover, iron, zinc, iodine,choline, and vitamins A, B6 (folate), B12, and D are crucial for braindevelopment in early life.
Purpose of the Study : Pedia Power is a powdered nutritionalformulation by Essen Fooddies India Pvt.Ltd. with nutrients that are essential to supplement children in improvingthe height, weight and brain development. It contains essential nutrients whichincludes- Carbohydrates, protein, fats, vitamins, minerals and essential aminoacids that helps the child in height, weight and brain development; It alsoaids in improving overall physical growth and supports Immunity.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Clinically healthy children between aged 5 and 14 years (both ages and all genders inclusive).
- •2.Children must be able to comprehend the language spoken and must have mastered verbal communication enough to understand and answer questions.
- •3.Children whose parents/guardian are willing to sign the informed consent for participation in the clinical study and are able to understand and ensure that their child/ward follows the responsibilities of the study.
- •4.Subjects who are willing to abstain from use of herbal, allopathic or other nutritional supplements that are indicated at improving general health.
- •5.Subjects who have scored ≤1 in STRONGKids Questionnaire at the time of screening.
- •6.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1.Subjects with known hypersensitivity to the ingredients of the investigational product.
- •2.Children who are identified with Galactosemia, Type I Diabetes Mellitus, Epilepsy and any other disorder that limits normal nutritional intake 3.Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
- •4.Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
- •5.Subjects on remission from cancer of any type less than 5 years at the time of screening 6.Subjects who have participated in a clinical study less than 1 month before screening 7.Any significant medical condition (e.g., significant psychiatric or neurological disorders), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
- •8.Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •9.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
结局指标
主要结局
1.Anthropometric Measurements: Improvement of 10% from baseline.
时间窗: 1. Anthropometric Measurements : Day 1, Day 45, Day 90 | 2. Fluency Test : Day 1, Day 45 Day 90 | 3. General Appetite : Day 1, Day 45, Day 90 | 4. IP Feedback Questionnaire : Day 90
2.Fluency Test: Improvement of 10% from baseline.
时间窗: 1. Anthropometric Measurements : Day 1, Day 45, Day 90 | 2. Fluency Test : Day 1, Day 45 Day 90 | 3. General Appetite : Day 1, Day 45, Day 90 | 4. IP Feedback Questionnaire : Day 90
3.General Appetite: Improvement of 10% from baseline.
时间窗: 1. Anthropometric Measurements : Day 1, Day 45, Day 90 | 2. Fluency Test : Day 1, Day 45 Day 90 | 3. General Appetite : Day 1, Day 45, Day 90 | 4. IP Feedback Questionnaire : Day 90
4.IPFBQ: Total Score of 20.
时间窗: 1. Anthropometric Measurements : Day 1, Day 45, Day 90 | 2. Fluency Test : Day 1, Day 45 Day 90 | 3. General Appetite : Day 1, Day 45, Day 90 | 4. IP Feedback Questionnaire : Day 90
次要结局
未报告次要终点