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Completed

NCT Number: NCT02495584

D-Light Intervention

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit

Coleraine, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fortified milk (10µg vitamin D3)

Dietary Supplement

Unfortified milk (placebo)

Dietary Supplement

10µg vitamin D3 supplement

Dietary Supplement

Placebo supplement

Dietary Supplement

Primary outcomes

  1. Change in vitamin D status (25-hydroxyvitamin D serum concentration)

    Time frame: Baseline + post-intervention (24weeks)

    Blood analysis

Secondary outcomes

  1. Change in body composition

    Time frame: Baseline + post-intervention (24weeks)

    Assessed by dual energy X-ray absorptiometry (DXA)

  2. Change in muscle strength

    Time frame: Baseline + post-intervention (24weeks)

    Assessed by grip strength

  3. Change in inflammation status

    Time frame: Baseline + post-intervention (24weeks)

    Blood analysis

  4. Change in lipid profile

    Time frame: Baseline + post-intervention (24weeks)

    Blood analysis

  5. Change in glucose levels

    Time frame: Baseline + post-intervention (24weeks)

    Blood analysis

  6. Change in insulin concentrations

    Time frame: Baseline + post-intervention (24weeks)

    Blood analysis

Other outcomes

  1. UV exposure (follow-up)

    Time frame: 8 weeks post-intervention (32-40 weeks)

    Assessed by UV wrist monitors

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Agri-Food and Biosciences Institute
  • Center for Nutrition and Health, RIVM (The Netherlands)
  • Dairy Council for Northern Ireland

Registry information

Official study title

D-Light Intervention: A Randomised Controlled Human Intervention Study to Assess the Impact of Vitamin D From Milk and Supplements on Functional Health Outcomes and Future Vitamin D Synthesis From UV Exposure

Acronym: D-Light

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2015
Registry last updated
Jan 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.