Effect of Ultraviolet Radiation on Blood Pressure, Cardiac Function and Insulin Sensitivity
A randomised phase III study to evaluate whether Ultraviolet Radiation B lowers blood pressure and insulin resistance and improves cardiac function in people with low vitamin D levels
Health Research Council of New Zealand
120 participants
May 20, 2006
Interventional
Conditions
Summary
The study hypothesis is that UVB, which increases body levels of vitamin D, when given to vitamin D deficient people in winter when the sun is weak, will lower blood pressure and insulin resistance, and improve cardiac function, compared with UVA which has no effect on vitamin D synthesis. All participants, both interviewers and myself will be blind to intervention. The UV is given by a nurse at a private dermatology clinic. She, the dermatologist at the clinic and the 3 members of an independent data monitoring committee, are the only people who know the allocation of the UV; plus a data entry person working for the data entry committee who keeps the baseline and follow-up bood results and who has no contact with participants.
Eligibility
Inclusion Criteria1
- Age - Pacific Island and Maori >50years, European >65years; 25OHD levels < 50 nmol/L.
Exclusion Criteria1
- Hypertension treated with thiazide diuretics, diabetes treated with insulin or oral hypoglycaemics, taking vitamin D supplements (including cod liver oil), planned travel to areas with high sun exposure during the study period.
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Interventions
A randomised double-blind clinical trial comparing ultraviolet B radiation (treatment) with ultraviolet A radiation (control), given twice weekly for 12 weeks. UVB will start at 400mJ/cm2 (with 20% increments) in the Pacific participants, and start at 200 mJ/cm2 (with 5% increments) in the European participants. UVA treatments will start with 1 J/cm2 the first week (with 1 J/cm2 weekly increases to 6 J/cm2 and maintained) in Pacific participants, and start at 0.5 J/cm2 (with 0.5 J/cm2 weekly increases up to 3 J/cm2 and maintained) in European participants. UVB increases vitamin D (in contrast with UVA which is the control).
Locations(1)
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ACTRN12607000021471