Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058440) titled 'The Effectiveness of Individual Health Guidance to Increase Serum Vitamin D Levels in Young Women' on July 14.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Doshisha Women's College of Liberal Arts, Graduate School
Condition:
Condition - Vitamin D insufficiency and deficiency
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the effect of individualized health guidance on increasing serum vitamin D concentrations in young women with insufficient or deficient serum vitamin D levels.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - For individuals with insufficient vitamin D intake, health guidance will be provided to increase vitamin D intake, followed by supplementation with a commercially available vitamin D supplement (25 ug per capsule per day) for 80 days.
For individuals with insufficient fat intake, health guidance will be provided to increase fat intake, followed by supplementation with a commercially available mixed nuts snack (6.0 g per pack), taken four days per week for 80 days.
For individuals with insufficient ultraviolet (UV) exposure, health guidance will be provided on safe UV exposure methods to increase vitamin D levels while minimizing potential risks.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Female
Key inclusion criteria - The participants in this study will be first-year undergraduate nursing students recruited through convenience sampling, who have provided informed consent and have serum 25(OH) vitamin D levels below 30 ng/mL.
Key exclusion criteria - Individuals with diseases that affect nutrient absorption, such as those with conditions damaging the small intestinal mucosa (e.g., Crohn's disease), those who have undergone extensive small intestine resection, or those with diseases causing lymphatic obstruction (e.g., intestinal lymphangiectasia)
Individuals with liver or kidney disorders affecting vitamin D metabolism
Individuals with a bleeding tendency, such as those with a history of difficulty stopping bleeding after blood collection or those taking anticoagulant medications
Individuals with allergies to apples, gelatin, or nuts
Individuals with skin damage or lesions
Individuals with photosensitivity
Individuals with anxiety about self-blood collection
Target Size - 16
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 07 Month 01 Day
Date of IRB - 2025 Year 07 Month 01 Day
Anticipated trial start date - 2025 Year 07 Month 14 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066798
Disclaimer: Curated by HT Syndication.