A Clinical Study on the Effect of DHA & ARA Candy on the Cognitive Improvement in Preschool Children
NCT Number: NCT06532435
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Change
Interventions: DIETARY_SUPPLEMENT: DHA & ARA Candy
Sponsor: Shandong Sibote Biotechnology Co., Ltd.
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-25
Completion Date: 2024-10-15
Locations: Raison Biotech Group Shanghai Lab, Shanghai, Shanghai, China

Summary:
The goal of this interventional study is to evaluate the effectiveness of DHA (docosahexaenoic acid) \& ARA (arachidonic acid) Candy on the cognitive development of preschool children (2-6 years old). The main questions it aims to answer are:

- Does DHA \& ARA Candy improve the cognitive ability in terms of Wechsler Intelligence Scale for Children 4th edition-Chinese version (WISC-IV-Chinese)?

Researchers will administer the WISC-IV-Chinese following the guidelines strictly and analyze the score to conclude whether the DHA \& ARA is effective to improve the cognitive ability of preschool childchildren.

Participants will eat 1-2 candy (each contains 100mg DHA and 100mg ARA) daily for 4 consecutive weeks and take the WISC-IV-Chinese test for three times according to the protocol.

Primary Outcome Measures: Change of scale of WISC-IV-Chinese asssessment in 2 weeks, Change of scale of WISC-IV-Chinese (Wechsler Intelligence Scale for Children 4th edition-Chinese version). The WISC-IV-Chinese is an individually administered and norm-referenced instrument designed to measure intelligence for Chinese children. The WISC-IV contains 10 core subtests and five additional subtests. These are summed into a four-index score and one FSIQ, which ranges from the lowest (40) to the highest (160) points., base day 0, week 2|Change of scale of WISC-IV-Chinese asssessment in 4 weeks, Change of scale of WISC-IV-Chinese (Wechsler Intelligence Scale for Children 4th edition-Chinese version). The WISC-IV-Chinese is an individually administered and norm-referenced instrument designed to measure intelligence for Chinese children. The WISC-IV contains 10 core subtests and five additional subtests. These are summed into a four-index score and one FSIQ, which ranges from the lowest (40) to the highest (160) points., base day 0, week 4
Secondary Outcome Measures: Change of Conners TRS score, Change in TRS (Conners' Teacher Rating Scale, TRS ) score over time during the intervention. The Teacher Rating Scales (TRS) are used to measure adaptive and problem behaviors in the preschool or school setting. Teachers or other qualified observers can complete forms at three age levels-preschool (ages 2 to 5), child (ages 6 to 11), and adolescent (ages 12 to 21). The Conners' Teacher Rating Scale we used is a 28-item instrument used to assess children's behavior, each item has four-choice options: 0 = Not True at All (Never, Seldom), 1 = Just a Little True (Occasionally), 2 = Pretty Much True (Often, Quite a Bit), and 3 = Very Much True (Very Often, Very Frequent). The total score ranges from 0 to 54; the smaller the score, the better the behavior., base day 0, week 2, week 4|Number of sick leave days, Number of sick leave days of participants during the intervention, base day 0, week 2, week 4