An Investigator-initiated Trial to Assess the Effectiveness of Three Different Gummies (Curcumin Gummies, Vitamin C Gummies, and Vitamin B Complex Gummies) in Healthy Children

NCT05775237 | Completed

• 1 other identifier: NB230001-NCP
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

An Open-Label, Three-Arm, Parallel, Investigator-Initiated Trial of Three Different Gummies (Curcumin Gummies, Vitamin C Gummies, and Vitamin B Complex Gummies) in Healthy Children. A sufficient number (maximum of 48, (16 children/arm)) of children subjects will be recruited to ensure a total of 45 subjects (15 children /arm) complete the study.

Conditions

Healthy Children

Outcome Measures

Primary Outcomes (3)

• Assessment of Safety

  To evaluate the Safety of Test Product by using subject perception questionnaires regarding Health

  Day 01 before test product usage to 30 Day after Test product usage

• Assessment of Efficacy

  To evaluate the Efficacy of Test Product by using subject perception questionnaires regarding Health

  Day 01 before test product usage to 30 Day after Test product usage

• Assessment of Organoleptic properties

  To evaluate the Organoleptic properties of Test Product by using subject perception questionnaires regarding Test Product

  30 Day after usage of Test product

Study Arms (3)

Curcumin Gummies

EXPERIMENTAL

Curcumin Gummies contain energy, dietary fiber, sugar, total carbohydrate, protein, fat, and curcumin.

Dietary Supplement: Curcumin Gummies

Vitamin C Gummies

EXPERIMENTAL

Vitamin C Gummies contain Vitamin C and Zinc

Dietary Supplement: Vitamin C Gummies

Multivitamin Gummies

EXPERIMENTAL

Multivitamin Gummies contain energy, dietary fiber, sugar, total carbohydrate, protein, fat, sodium, Vitamin C, Vitamin E, pantothenic acid, Zinc, iodine, Vitamin A, Magnesium, Folate, Vitamin D, Vitamin 12

Dietary Supplement: Multivitamin Gummies

Interventions

Curcumin Gummies DIETARY_SUPPLEMENT

Chew gummies thoroughly and completely before swallowing.

Also known as: curcumin

Curcumin Gummies

Vitamin C Gummies DIETARY_SUPPLEMENT

Chew gummies thoroughly and completely before swallowing.

Also known as: Vitamin C

Vitamin C Gummies

Multivitamin Gummies DIETARY_SUPPLEMENT

Chew gummies thoroughly and completely before swallowing.

Also known as: Multivitamin

Multivitamin Gummies

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age: 02 to 12 years old (both inclusive) at the time of parental consent.
• Overall good health of the child subject is determined by medical examination and history evaluated by the Investigator.
• Subject's mother/legal guardian, preferably willing to give a voluntary written informed consent i.e. parental informed consent form and agree to complete study activities and come for regular follow-up with a subject.
• The subject's mother/legal guardian for their child is preferably willing to abide by and comply with the study protocol.
• The subject should not participate in any other clinical study during participation in the current study
• Subject are agreed to maintain current level of activity through the study.

You may not qualify if:

• Subjects with known history of allergies or specific allergic reactions upon using curcumin, vitamins, zinc, pantothenic acid.
• Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
• Subjects, who in the opinion of the Investigator or the Expert physician are not eligible for enrolment in the study.
• Subject who are unwilling to provide consent.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead

Study Sites (1)

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, 382421, India

Location

MeSH Terms

Interventions

Curcumin; Ascorbic Acid; Geritol

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Dr. Chitra Prajapati, MBBS

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This Study is Open-label
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: An Open-Label, Three-Arm, Parallel, Investigator-Initiated Trial of clinical study

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 20, 2023
• Study Start: May 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 6, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)