Trials / Unknown
UnknownNCT04341818
Vitamin D and Resistance Exercise in Elderly (NUTRIAGINGVitD)
Vitamin D and Resistance Exercise in Elderly
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- University of Vienna · Academic / Other
- Sex
- All
- Age
- 65 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
The aim of this randomized, double-blind, controlled intervention study with parallel groups is to investigate the effect of resistance training (2x/week for 10 weeks) with and without different goals of vitamin D intake on muscle strength, function and mass, oxidative stress parameters and the immune system in community dwelling persons. Participants (n = 100) will be community-dwelling older adults. After a preparticipation screening and a vitamin D blood investigation (vitamin D status below 75 nmol/L) participants will be distributed randomly but stratified by sex, age and initial vitamin D plasma levels to one of the 3 groups (Vitamin D daily + strength training, Vitamin D monthly + strength training, no Vitamin D + strength training). Study participants are eligible if they are male or female with an age between 65 and 85 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the training sessions, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, a frailty index at or above 3, medication with anticoagulants or cortisone drugs, a regular strength training during the last six months and a vitamin D plasma concentration of 75nmol/L or above. Primary outcome measure is the change in the handgrip strength. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters, DNA/Chromosomal damage microbiota, metabolomics and the nutritional status.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Strength Training and Vitamin D monthly | For 4 wks 50.000 IU vitamin D is given as a monthly dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D and calcium intake remain. |
| OTHER | Strength Training and Vitamin D daily | For 4 wks 800 IU vitamin D is given as a daily dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D and calcium intake remain. |
| OTHER | Strength Training and no Vitamin D | For 4 wks no vitamin D is administered, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the also no vitamin D is given. Over the whole study period participants get 400 mg calcium/day. |
Timeline
- Start date
- 2019-01-15
- Primary completion
- 2019-08-20
- Completion
- 2021-12-01
- First posted
- 2020-04-10
- Last updated
- 2020-04-13
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT04341818. Inclusion in this directory is not an endorsement.