Study on Pedia Power - A Nutritonal Supplement for Children

Phase 3

Completed

Conditions: Clinically Healthy Children aged between 5 and 14 years

Registration Number: CTRI/2022/08/044567

Lead Sponsor: Essen Fooddies India Pvt Ltd

Brief Summary: **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, itâ€™simportant for them to get enough vitamins and minerals to ensure optimal healthand also itâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

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 â‰¤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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Anthropometric Measurements: Improvement of 10% from baseline.	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.	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.	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.	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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Raam Clinic
🇮🇳
Chennai, TAMIL NADU, India
Raam Clinic
🇮🇳Chennai, TAMIL NADU, India
Dr VT Sriraam
Principal investigator
9840909155
md@auroushealthcare.com