Clinical Trial: Effects of improvement in vitamin D nutritional status on health outcomes in middle-aged and older women: a randomized three-arm parallel-group trial combining exercise and vitamin D supplementation (Study I) (Japan)

Tokyo, Sept. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062989) titled 'A comparative trial of vitamin D supplementation and exercise on health outcomes in middle-aged and older women' on Sept. 19.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Japan Nutrition University

Condition: Condition - Risk of vitamin D insufficiency or deficiency, bone and calcium metabolism, and health status related to frailty and locomotive syndrome prevention Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the effects of vitamin D supplementation at 50ug/day (2,000 IU/day), alone or in combination with exercise, on serum 25-hydroxyvitamin D [25(OH)D], serum calcium, whole parathyroid hormone (PTH), and bone turnover markers among community-dwelling middle-aged and older women during the autumn-winter season. Secondary objectives are to explore the effects on muscle strength, physical function, bone density, neuromuscular function, self-reported health status, sleep, skin condition, common cold symptoms, and pain-related outcomes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Group A, vitamin D supplementation alone: No exercise instruction. Participants will take an active study tablet containing vitamin D 50 ug/day (2,000 IU/day) for 3 months. Interventions/Control_2 - Group B, exercise alone: Participants will attend a supervised exercise class once weekly for 75 minutes, 12 sessions in total, and take a placebo tablet for 3 months. The exercise program consists of stretching, resistance exercise, aerobic exercise, and coordination exercise with progressive intensity increased every 2 weeks under the supervision of physical therapists.

Eligibility: Age-lower limit - 40 years-old = Gender - Female Key inclusion criteria - 1. Women aged 40 to 79 years as of March 31, 2027 2. Not receiving strict dietary guidance from a physician or other health professional 3. Not engaging in regular moderate or higher intensity exercise at least twice per week 4. Not regularly taking supplements for osteoporosis prevention containing vitamin D 5. Not currently receiving treatment for osteoporosis, diabetes mellitus, chronic kidney disease, thyroid disease, or related conditions 6. Able to provide written informed consent Key exclusion criteria - 1. Individuals judged unable to continue the 3-month intervention program 2. Individuals with safety concerns regarding intake of the study food, participation in exercise classes, blood or urine sampling, or physical function measurements 3. Individuals judged by the principal investigator or co-investigators to be inappropriate for participation Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 15 Day Date of IRB - 2026 Year 08 Month 05 Day Anticipated trial start date - 2026 Year 09 Month 19 Day Last follow-up date - 2026 Year 12 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072003

Disclaimer: Curated by HT Syndication.