D-Light Intervention

NCT ID: NCT02495584

Last Updated: 2016-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-10-31

Brief Summary

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Vitamin D insufficiency has become a global concern, with low vitamin D status associated with bone disorders, cardiovascular disease and certain cancers. The United Kingdom (UK) and Ireland are at particular risk of vitamin D deficiency owing to the northerly latitude, increased use of sunscreen, decreased sun exposure and a high level of cloud cover. A recent survey in the UK showed that more than 50% of UK adults have insufficient vitamin D status, with lower levels noted in the winter months. Variations in vitamin D status have been known to vary between summer and winter, owing to our northern latitude (52-55°N) the Ultraviolet (UV)-B intensity in Northern Ireland is inadequate to promote the dermal synthesis of vitamin D during the winter months, causing us to rely on dietary sources. The aim of this intervention is to investigate the main effects of vitamin D3-fortified milk and supplemental vitamin D3 on vitamin D status and functional health outcomes during the winter, and how this intervention will affect subsequent dermal synthesis of vitamin D from UV exposure. Participants will be recruited from the local community. Blood samples will be collected from each participant at two timepoints (September/October and March/April). Pre- and post-intervention blood pressure, grip strength, height, weight, waist and hip circumferences will be measured, in addition participants will undergo a dual energy x-ray absorptiometry (DXA) scan to assess body composition and bone mineral density. Information on general health, lifestyle, physical activity, dietary intake and typical behaviours in the sun will be collected. Following the dietary intervention, a subset of participants will be invited to participate in a follow-up study, examining UV exposure during the summer months, when they will wear a personal wrist dosimeter for 1 month, complete a sun dairy and provide 2 additional blood samples.

Detailed Description

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Conditions

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25-hydroxyvitamin D Concentration (Vitamin D Status)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment 1

500ml fortified milk (10µg vitamin D3) +1 supplement capsule (10µg vitamin D3) daily for 24 weeks

Group Type EXPERIMENTAL

Fortified milk (10µg vitamin D3)

Intervention Type DIETARY_SUPPLEMENT

10µg vitamin D3 supplement

Intervention Type DIETARY_SUPPLEMENT

Treatment 2

500ml fortified milk (10µg vitamin D3) +1 supplement capsule (placebo) daily for 24 weeks

Group Type EXPERIMENTAL

Fortified milk (10µg vitamin D3)

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Treatment 3

500ml unfortified milk (placebo) +1 supplement capsule (10µg vitamin D3) daily for 24 weeks

Group Type EXPERIMENTAL

Unfortified milk (placebo)

Intervention Type DIETARY_SUPPLEMENT

10µg vitamin D3 supplement

Intervention Type DIETARY_SUPPLEMENT

Treatment 4

500ml unfortified milk (placebo) +1 supplement capsule (placebo) daily for 24 weeks

Group Type PLACEBO_COMPARATOR

Unfortified milk (placebo)

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Fortified milk (10µg vitamin D3)

Intervention Type DIETARY_SUPPLEMENT

Unfortified milk (placebo)

Intervention Type DIETARY_SUPPLEMENT

10µg vitamin D3 supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 20-40 years old
* Apparently healthy
* Living on the island of Ireland

Exclusion Criteria

* Below 20 years and aged 40 years or above
* Not living on the island of Ireland
* Pregnant or lactating women and those planning to become pregnant
* Individuals who have been taking a vitamin D or calcium containing supplement in the previous three months
* Those with food intolerances or allergies that would affect their ability to consume study milk
* Individuals following a diet which excludes milk (e.g. vegans)
* Those with a diagnosed chronic medical condition or on prescribed medication known to effect vitamin D metabolism
* Those who are planning a sun holiday during the winter months (Oct-Mar)
* Adults with learning, or any other difficulties that would prevent them from completing the study protocol
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dairy Council for Northern Ireland

OTHER

Sponsor Role collaborator

Agri-Food and Biosciences Institute

OTHER

Sponsor Role collaborator

Center for Nutrition and Health, RIVM (The Netherlands)

UNKNOWN

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Human Intervention Studies Unit

Coleraine, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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13/NI/0091

Identifier Type: -

Identifier Source: org_study_id

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