UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062041 |
|---|---|
| Receipt number | R000070989 |
| Scientific Title | Single-ingredient Vitamin D3 3200 IU versus Vitamin D3 3200 IU/Zinc/Quercetin Supplementation in Adult Indonesian Women: A Pilot Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/24 |
| Last modified on | 2026/06/24 12:43:12 |
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Basic information
Public title
Single-ingredient Vitamin D3 3200 IU versus Vitamin D3 3200 IU/Zinc/Quercetin Supplementation in Adult Indonesian Women: A Pilot Randomized Controlled Trial
Acronym
Single vs Vitamin D Combination: A Pilot RCT
Scientific Title
Single-ingredient Vitamin D3 3200 IU versus Vitamin D3 3200 IU/Zinc/Quercetin Supplementation in Adult Indonesian Women: A Pilot Randomized Controlled Trial
Scientific Title:Acronym
Single vs Vitamin D Combination: A Pilot RCT
Region
| Asia(except Japan) |
Condition
Condition
vitamin D deficiency/insufficiency in healthy adult Indonesian women
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in serum 25-hydroxyvitamin D [25(OH)D] levels from baseline to 8 weeks after supplementation
Key secondary outcomes
- Changes in hematological parameters (hemoglobin, hematocrit, erythrocyte count, leukocyte count)
- Changes in body composition (body fat percentage, visceral fat, muscle mass, total body water)
- Correlation between changes in vitamin D levels and immunometabolic parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Linawati |
| Middle name | |
| Last name | Hananta |
Organization
Faculty of Medicine and Health Sciences, Universitas Katolik Indonesia Atma Jaya
Division name
Pharmacology
Zip code
14440
Address
Jl. Pluit Raya No. 2, Penjaringan, North Jakarta 14440, Special Capital Region of Jakarta, Indonesia.
TEL
+6281383777800
linawati.hananta@atmajaya.ac.id
Public contact
Name of contact person
| 1st name | Linawati |
| Middle name | |
| Last name | Hananta |
Organization
Faculty of Medicine and Health Sciences, Universitas Katolik Indonesia Atma Jaya
Division name
Pharmacology
Zip code
14440
Address
Jl. Pluit Raya No. 2, Penjaringan, North Jakarta 14440, Special Capital Region of Jakarta, Indonesia
TEL
+6281383777800
Homepage URL
linawati.hananta@atmajaya.ac.id
Sponsor or person
Institute
Three International Wellness Technology Indonesia.
Institute
Department
Personal name
Funding Source
Organization
Three International Wellness Technology Indonesia.
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Medicine and Health Sciences Atma Jaya Catholic University of Indonesia
Address
Jl. Pluit Raya No. 2, Penjaringan, North Jakarta 14440, Special Capital Region of Jakarta, Indonesia
Tel
+62 21 669 3168
kep.fkik@atmajaya.ac.id
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
86
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 24 | Day |
Last modified on
| 2026 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070989
