- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02599675
Vitamin D Supplementation and Muscle Characteristics in Trained Subjects
Effects of 12 Weeks of Vitamin D Supplementation on Muscle Characteristics in Trained Subjects
연구 개요
상세 설명
Vitamin D insufficiency compromises muscle functionality, leading to changes in muscle mass and strength, manifested at the cellular level. While this is increasingly recognized as a problem for individuals with vitamin D deficiency (typically 25(OH)D < 25 nmol/l), there is no general consensus for the remainder of the vitamin D-spectra. This lack of knowledge is probably linked to the variation in protocols of studies that have investigated the physiological role of vitamin D. These variations vary from aspects such as interventional vs observational studies to aspects related to subject characteristics such as age, health and training status. In this project, we will evaluate the effects of 12 weeks of vitamin D supplementation (2000 IU/day) on muscle performance and characteristics in 70 trained healthy individuals (18-40 years of age). Subjects will be allocated to either a vitamin D (35) or a placebo group (35) in a double-blinded manner. They will be instructed to continue their ordinary modes and frequency of training.
We anticipate baseline vitamin D levels in blood (and hence changes in vitamin D obtained through supplementation), measured as 25(OH)D, to be a major determinant of the efficacy of the intervention. This means that we expect individuals with low baseline levels of 25(OH)D to display more pronounced changes in functional and biological outcome measures than those with high baseline values. Such a scenario could be related to an inability of our protocol to increase blood levels of 25(OH)D in individuals with higher physiological levels of vitamin D (which essentially means that ingestion of vitamin D3 is leveled out or exceeded by elimination of vitamin D derivatives). Alternatively, it may be related to inabilities of tissues to respond to the resulting elevation in vitamin D levels. To study the individual variation in vitamin D responses, data on both functional and biological variables will be divided into quartiles based on baseline 25(OH)D-levels, whereupon comparisons will be made between the low-end and high-end quartile. Individual variation will also be assessed using a mixed model approach.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Lillehammer, 노르웨이
- Lillehammer University College
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Individuals that have performed strength and / or endurance exercise training at least 3 X week for at least 6 months prior to the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Vitamin D3
Vitamin D3 capsules for 12 weeks (2000 IU daily, equivalent to 50 ug)
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올리브 오일에 용해된 비타민 D3, 캡슐화
다른 이름들:
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위약 비교기: Placebo
Placebo capsules for 12 weeks (the number of daily capsules will match that of the vitamin D-group)
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캡슐에 담긴 올리브 오일
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Lower body maximal dynamic strength
기간: wk 0, wk12
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Changes in the ability of lower body muscles to exert maximal force during a dynamic movement
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wk 0, wk12
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Muscle fiber composition
기간: wk0, wk12
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Changes of the muscle fiber composition of musculus vastus lateralis in a 2X to 2A direction, measured using mRNA profiling
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wk0, wk12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gene expression in muscle
기간: wk0, wk12
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Changes in RNA abundances in musculus vastus lateralis, measured at the level of single genes
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wk0, wk12
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Vitamin D in blood
기간: wk0, wk12
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Changes in levels of 25(OH)D in blood
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wk0, wk12
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Steroid hormones in blood
기간: wk0, wk12
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Changes in levels of steroid hormones in blood
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wk0, wk12
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Muscular endurance
기간: wk0, wk12
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Changes in the ability of muscles to perform repeated dynamic contractions at submaximal loads (50% of 1 repetition maximum)
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wk0, wk12
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Upper body maximal dynamic strength
기간: wk0, wk12
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Changes in the ability of upper body muscles to exert maximal force during dynamic movements
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wk0, wk12
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Training diary
기간: From 1 month prior to study to post test (w12)
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Diary that includes information on type of training, duration and intensity performed
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From 1 month prior to study to post test (w12)
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Vitamin D-intake diary
기간: From 1 month prior to study to post test (w12)
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Diary withthat includes information on approximate intake of vitamin D from sources other than the study-specific supplement, including ingestion of fish, seafood and vitamin D-supplement
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From 1 month prior to study to post test (w12)
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Sun exposure diary
기간: From 1 month prior to study to post test (w12)
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Diary that includes information on exposure to solarium or sun in countries south of Norway
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From 1 month prior to study to post test (w12)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Håvard Nygaard, MSc, Inland Norway University of Applied Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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