Evaluation of Vitamin D Supplementation on heart health, muscle strength and Body fat in twins

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-3qy2f2
• Date of registration: 05/09/2017
• Prospective Registration: No
• Primary sponsor: Pós Graduação em Ciências da Saúde
• Public title: Evaluation of Vitamin D Supplementation on heart health, muscle strength and Body fat in twins
• Scientific title: Supplementation with Vitamin D assessment on Physical Fitness: study heritability
• Date of first enrolment: 01/04/2016
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-3qy2f2
• Study type: Intervention
• Study design: Prevention study, parallel two-arm, randomized controlled, prospective study, open.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Jeane Pires Medeiros
• Affiliation: Universidade Federal do Rio Grande do Norte

• Name: Jeane Pires Medeiros
• Affiliation: Universidade Federal do Rio Grande do Norte

Key inclusion & exclusion criteria

Inclusion criteria: Pairs of twins of the same sex. aged 20 and 45. healthy.
Exclusion criteria: individuals with physical disabilities or musculoskeletal limitations that prevent walking or running activity; indivíuos drug therapy related to obesity or using vitamin supplement containing vitamin D; pairs of twins of different sexes; individuals with conditions such as hypertension, diabetes, liver disease, heart disease, infectious or some chronic degenerative disease; pregnant women and individuals who have negative responses to the Physical Activity Readiness Questionnaire (PARq).

Age minimum:
Age maximum: 45Y
Gender: -

Health Condition(s) or Problem(s) studied

M01.774.500

M01.438.873

twins, healthy volunteers

Intervention(s)

Group 1 (control): 50 twin Monozygotic and dizigotos without treatment, did not receive vitamin D supplementation after the physical fitness tests, tests and collections will be made at two different times as follows: the first day will be collected blood, data cardiorespiratory fitness, muscle strength data and densitometry. On the second day (two months after the first collection) will be collected blood, cardiorespiratory fitness data, muscle strength data and densitometry.
Group 2 (with treatment): 50 twin Monozygotic and dizigotos which receive supplementation one capsule daily vitamin D in form of cholecalciferol for a period of 60 days, the tests and samplings are made at two different times as follows: in the first day will be collected blood, cardiorespiratory fitness data, muscle strength data and densitometry. On the second day (two months after the first collection) will be collected blood, cardiorespiratory fitness data, muscle strength data and densitometry.

Dietary supplement

SP6.051.227

Primary Outcome(s)

Expected outcome: Increased vitamin D concentration in the supplemented group and improved cardiorespiratory fitness and muscle strength after 60 days of supplementation. Evaluation will be performed on the first day of recruitment and 60 days later. To check the increase in vitamin D concentration is used the method of electroluminescence and to verify the improvement of cardiorespiratory fitness will be used ergo spirometer test and analyze muscle strength dynamometry the scapular test and manual will be done.
For determining the expected outcome were taken into account the 95% confidence intervals and alpha of 0.05, obtaining a minimum required aostra 50 twins and 50 Monozygotic dizigotos twins. Which will be distributed as follows: group 1, 25 twins and 25 Monozygotic twins dizigotos, in group 2, 25 twins and 25 Monozygotic dizigotos twins.

Secondary Outcome(s)

Expected outcome: To assess the concentration of vitamin D in both groups meets the nutritional recommendations for the study population and influence in cardiorespiratory fitness and muscle strength. For finding the expected outcomes, the difference between the value established as normal and the value found in each group evaluated before and after supplementation is considered.

Source(s) of Monetary Support

Universidade Federal do Rio Grande do Norte

Secondary Sponsor(s)

Universidade Federal do Rio Grande do Norte