Tokyo, June 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062041) titled 'Single-ingredient Vitamin D3 3200 IU versus Vitamin D3 3200 IU/Zinc/Quercetin Supplementation in Adult Indonesian Women: A Pilot Randomized Controlled Trial' on June 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Three International Wellness Technology Indonesia.
Condition:
Condition - vitamin D deficiency/insufficiency in healthy adult Indonesian women
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate and compare the effectiveness of a vitamin D combination formulation (vitamin D3, zinc bisglycinate, and quercetin phytosome) versus vitamin D3 monotherapy in improving vitamin D status, immunological markers, hematological parameters, and body composition in healthy Indonesian adult women.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intervention group: Vitamin D3 3200 IU combined with zinc bisglycinate and quercetin phytosome (Imune), administered orally once daily for 8 weeks
Interventions/Control_2 - Control group: Vitamin D3 3200 IU monotherapy, administered orally once daily for 8 weeks.
Eligibility:
Age-lower limit - 18
years-old
Gender - Female
Key inclusion criteria - Healthy adult women aged 18-65 years
No history of chronic disease( e.g cardiovascular, liver, kidney, diabetes, autoimnune disorders)
Not taking vitamin D supplementation within at least 2 weeks prior to study
Willing to participate and provide informed consent
Key exclusion criteria - Pregnancy or breastfeeding
Use of medications affecting vitamin D metabolism (e.g., corticosteroids, antiepileptics, statins, metformin)
Presence of chronic illnesses
Current participation in other clinical studies
Target Size - 86
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 05 Month 09 Day
Date of IRB - 2025 Year 05 Month 09 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2025 Year 10 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070989
Disclaimer: Curated by HT Syndication.
