Vitamin D and Resistance Exercise in Elderly (NUTRIAGINGVitD)

NCT ID: NCT04341818

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2021-12-31

Brief 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

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Strength Training and Vitamin D monthly

Four weeks of Vitamin D (50.000 IU once per month) followed by a 10 week guided 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 intake remains. Over the whole study period participants get 400 mg calcium/day.

Group Type: EXPERIMENTAL

Strength Training and Vitamin D monthly

Intervention Type: OTHER

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.

Strength Training and Vitamin D daily

Four weeks of Vitamin D (800 IU once per day) followed by a 10 week guided 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 intake remains. Over the whole study period participants get 400 mg calcium/day.

Group Type: EXPERIMENTAL

Strength Training and Vitamin D daily

Intervention Type: OTHER

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.

Strength Training and no Vitamin D

Four weeks of no vitamin D administration followed by a 10 week guided 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 intake remains. Over the whole study period participants get 400 mg calcium/day.

Group Type: EXPERIMENTAL

Strength Training and no Vitamin D

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males and females between the age of 65 and 85 years
• Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State >23)
• Independently mobile

Exclusion Criteria

• Chronic diseases, which contraindicate a training participation
• Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
• Diabetic retinopathy
• Manifest osteoporosis
• Regular use of cortisone-containing drugs
• Regular strength training (> 1x / week) in the last 6 months before inclusion
• Vitamin D plasma level of 75 nmol/l or above

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Karl-Heinz Wagner

Professor of Human Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

FA219002_2

Identifier Type: -

Identifier Source: org_study_id