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Vitamin D status of Australian women

Determinants of vitamin D status (as measured by 25(OH)D and dietary intake) in women: the role of environmental factors, ethnicity and diet

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620001140943
Acronym
VDAW
Enrollment
42
Registered
2020-11-02
Start date
2020-09-01
Completion date
2021-08-24
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Vitamin D deficiency remains a global public health issue, with clinical rates growing. Vitamin D deficiency is well known to be linked to musculoskeletal conditions, however there is also strong epidemiological evidence linking deficiency with diabetes, cardiovascular disease, osteoporosis, osteoarthritis and some cancers. The condition has a significant financial impact on not only individuals, but also the economy, therefore is of public health importance. As majority of vitamin D is synthesised through cutaneous exposure to the sun, it is unlikely that vitamin D deficiency is perceived to be an issue for much of the Australian population. However, vitamin D deficiency is prevalent in Australia, due to the many individual and environmental factors that impact on vitamin D status, such as skin colour, dressing habits, latitude and season. The Australian Health Survey 2011-12 identified that 23% of the population were vitamin D deficient (defined as <50nmol/L), which equivalates to approximately 4 million people (ABS 2014). Our study will look at the vitamin D status of women living in Australia in winter 2020/2021. This study will take place in Wollongong, on the South East Coast of Australia, Latitude 34.42° S, 150.89° E. We will determine which factors such as dietary intake, sun exposure and muscular strength contribute to vitamin D status. The findings of this study will not only fill this gap in the knowledge, but may also contribute to the literature which informs public health policy on vitamin D.

Interventions

This is an observational study which will require one visit to the IHMRI clinical trials area/building 41, at the University of Wollongong. The visit will take place in winter 2020 and winter 2021 (June-August). The duration of the visit will last approximately 2 hours, and the total duration of involvement in the study will last 4 days, to include the time wearing the dosimeter and filling in the 4 day food diary. Of these 4 days, one day will be a weekend day. Recruited participants will come

This is an observational study which will require one visit to the IHMRI clinical trials area/building 41, at the University of Wollongong. The visit will take place in winter 2020 and winter 2021 (June-August). The duration of the visit will last approximately 2 hours, and the total duration of involvement in the study will last 4 days, to include the time wearing the dosimeter and filling in the 4 day food diary. Of these 4 days, one day will be a weekend day. Recruited participants will come to IHMRI clinical trials area/building 41 fasted. The following measurements will be taken: 1. Consent taking Consent will be taken by the trained investigators at the beginning of the session. The participants will be given ample time to read and understand each point within the consent form and be giving time to ask any questions before initialling and signing off. Participants will be made aware that they do not have to take part, and that there will be no adverse consequences if they do not participate. 2. Anthropometric measurements The following anthropometrical measurements will be taken from each participant: Weight, height, waist to hip ratio, waist circumference, waist to height ratio and body composition. Weight and body composition will be measured to the nearest 0.1kg. This will be achieved using a Tanita Body Composition Analyser BC-418. Standing height will be measured using a wall stadiometer, to the nearest 0.1cm. Waist and hip circumference will be measured using a non-extendable standard measure tape, at the narrowest point of the torso for waist measurement (if this cannot be estimated, the level of the belly button will be used as a reference point), and the widest part of the hips for the hip measurement, to the nearest 0.1cm. Waist to hip ratio will be calculated by dividing the waist measurement by the hip measurement (waist ÷ hip) and the waist to height ratio will be calculated by dividing the waist measurement by the height measurement (waist ÷ height) 3. Dual energy X-ray absorptiometry (DEXA) scan Two DEXA scans will be taken. One scan to assess whole body bone mineral density and body composition, and the other to specifically assess fracture risk by scanning the femoral the hip and femoral head. Effective exposure doses for these scans are approximately 9 uSv and 8 uSv respectively. Total research protocol dose is approximately 18 uSv, this is equivalent to approximately 3 days of natural background radiation. Prior to the DEXA scan, participants will take a pre-scan questionnaire, which includes declaring they are not pregnant. Participants will be given the option to take a pregnancy test before the DEXA scans. 4. Blood sample An 8 hour-fasted blood sample will be taken by a trained phlebotomist. The following collection tubes will be used: • 2 x 10ml BD Vacutainer® SSTTM (red top) tube: serum 25OHD, calcium and albumin, P1NP, CTX, lipid profile, micronutrient status • 6ml BD Vacutainer® EDTA (purple) tube: PTH plasma, blood glucose level Blood sampling will occur once, with approximately 30ml of blood taken. Serum 25(OH)D for the analyses of vitamin D status will be sent to the University of Sao Paulo, Brazil for analysis. The remaining analytes will be analysed in laboratories in Australia. Calcium and P1NP and CTX (bone markers) are directly related to vitamin D status due to the role of vitamin D in calcium homeostasis, and this bone health. We are including these measures in order to assess the effect of vitamin D status on musculoskeletal health. Because vitamin D is a fat-soluble vitamin and is stored in adipocytes, it is necessary to have an indication of participants’ lipid status. Regarding micronutrient status, we will investigate those micronutrients known to impact on vitamin D status, namely the minerals serum calcium and phosphorus. Blood samples will be stored at -80°C at the University of Wollongong. 5. International Physical Activity Questionnaire (IPAQ) short form A physical activity questionnaire will be undertaken to obtain data on physical activity in everyday lives. 6. Sun exposure questionnaire The sun exposure questionnaire measures how often participants spend in the sun across different seasons, what body parts were exposed and if they have been on a recent summer holiday. This questionnaire was designed specifically for this study. 7. Lifestyle questionnaire The lifestyle questionnaire measures a range of factors including skin type, medical history, education, behaviours and attitudes towards sun exposure and knowledge and consumption of vitamin D. This questionnaire was designed specifically for this study. 8. Sit-to-stand test The 30 second Sit to Stand Test is used to measure leg strength and endurance. A chair without arms will be placed against a wall to prevent slipping. The participant will sit in the chair with their back straight, feet shoulder width apart on floor, with their arms crossed at their wrists and held against the chest. If the participant uses their arms to stand up they are scored 0. The participant will complete as many full stands as possible within 30 seconds. 9. Grip strength test The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. Placing their arm at a right angle with the elbow at the side of the body, the participant will use their non-dominant hand to hold the hand grip dynamometer. The participant will squeeze the dynamometer with maximum effort for 5 seconds. An average of three tests will be taken, to the nearest 0.1kg. 10. Instruction on how to complete a 4-day food diary 4-day food diaries will be kept to measure dietary intake, in particular, intake of vitamin D. These will be used at home for four days, one of which days will be a weekend day. The participants are asked to record the time, what they eat, method of cooking and the amount eaten. They will be instructed to send these back to the investigators using the freepost envelopes provided. The researchers may phone or email the participants if any further information of their diet is required. Data will be analysed using Foodworks® nutritional analysis software. This diary was designed specifically for this study. 11. Instructions on how to wear a dosimeter to measure UVB exposure Participants will be asked to wear a dosimeter polysulphone film badge to measure UVB exposure. The dosimeters are clipped to the outer clothing with a pin, worn on the upper chest/shoulder region. Individuals are asked to wear the badge on from sunrise to sunset, for 4 days, one of which will be a weekend day. They are instructed to store the dosimeter in the supplied envelope (of thick and dark material to prevent further UVB exposure during storage) until returning. Data will be read pre and post use at the University of Southern Queensland. A x Spectophotometer (CV <1%) will be used at 330nm to detect a change in absorbency. Results of individual badge doses are reported in standard erythema dose (SED) units (1 SED = 100 J/m2).

Sponsors

University of Wollongong
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

• Women • Australian - Self-reported ethnicity • Living in Australia for >2 months • Aged 18-35 or >55 years • No significant health issues • Pre-menopausal (regular menstrual periods) or Post-menopausal (menstrual periods stopped for longer than 12 consecutive months)

Exclusion criteria

• Women in perimenopause or menopause • Pregnant or planning pregnancy during study period • Hypercalcaemia (>2.5mmol/L) – assessed and excluded at baseline • Currently receiving treatment for medical conditions that are likely to affect vitamin D metabolism (osteoporosis, hormone replacement therapy, anti-estrogens treatment, antiepileptic drugs and breast cancer treatment) • Regular use of sun beds • Having a sun holiday one month prior to participation in study • Women who take vitamin D or calcium supplements (or multivitamin supplements that contain these vitamins) • Living in Australia for less than 2 months

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026