Vitamin D and Health Status of British African-Caribbean Women

NCT04179370 | Recruiting

• 1 other identifier: SPON 2019 025 FHMS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D deficiency remains a global public health issue (Wilson 2017). In the United Kingdom (UK). There is a lack of research looking at vitamin D status of the British African-Caribbean population. This population is particularly at risk to vitamin D deficiency due to possessing a skin type which hinders the production of vitamin D in the skin. Further, due to the geographical location of the UK, there is reduced ability to produce vitamin D due to the low sun exposure (Libon 2013 ). Our main source of vitamin D is through skin exposure to the sun. In the UK, the UV radiation is only strong enough in April-September (Wilson 2017) for the production of vitamin D to occur. In winter months, vitamin D needs to be consumed in food or supplement form. Vitamin D is essential for healthy bones and is associated with reduced risk of certain cancers and immune disorders (Wilson 2017). There is strong epidemiological evidence linking low vitamin D status with diabetes, cardiovascular disease, osteoporosis, osteoarthritis and some cancers (NatCen 2018). This observational study will aim to determine the vitamin D status of British Afro-Caribbean women, as well as determine the effects of sun exposure, dietary vitamin D intake, muscular strength, lifestyle and anthropometrical (height, weight etc.) factors have on vitamin D status. The study will be conducted at the University of Surrey. The study will take place in Autumn and winter 2019/2020 and a repeat study in Spring 2020. Each participant will require two visits to the university, each session will take approximately 2 hours. The study is funded by the University of Surrey. The findings of this study may lead to strategies for improving vitamin D status in this population, as well as improving guidelines to assist darker-skinned people regarding sunlight exposure in high latitudes.

Conditions

Vitamin D Deficiency

Keywords

vitamin D OR 25(OH)D; African-Caribbean OR Afro-Caribbean

Outcome Measures

Primary Outcomes (11)

• Vitamin D (serum 250HD) status

  A blood sample will be taken from participants. This will be analysed using liquid chromatography tandem mass spectroscopy (LC-MS)

  One measurement at baseline

• Change in vitamin D status

  A blood sample will be taken from participants. This will be analysed using liquid chromatography tandem mass spectroscopy (LC-MS)

  The first measurement will be performed in winter 2020, with a repeat measurement approximately 3 months later in spring 2020.

• Bone mineral composition

  Peripheral computed tomography (pQct) scan

  One measurement at baseline

• Dual energy X-ray absorptiometry (DEXA) of whole body

  Assess bone mineral density

  One measurement at baseline

• Dual energy X-ray absorptiometry (DEXA) of femoral head

  Assess fracture risk

  One measurement at baseline

• Change in blood bone marker

  P1NP (bone markers) will be measured from blood

  The first measurement will be performed in winter 2020, with a repeat measurement approximately 3 months later in spring 2020.

• Change in blood bone marker

  CTX (bone marker) will be measured from blood

  The first measurement will be performed in winter 2020, with a repeat measurement approximately 3 months later in spring 2020.

• Vitamin D intake

  Vitamin D intake will be measured through a 4-day food diary which participants will fill out for 4 day at home after the study

  One measurement at baseline

• Change in vitamin D intake

  Vitamin D intake will be measured through a 4-day food diary which participants will fill out for 4 day at home after the study

  The first measurement will be performed in winter 2020, with a repeat measurement approximately 3 months later in spring 2020.

• Sun exposure

  sun exposure will be measured by a dosimeter which measures UVB exposure. Participants wear this like a badge, for 4 days after the study

  One measurement at baseline

• Change in sun exposure from winter to spring

  sun exposure will be measured by a dosimeter which measures UVB exposure. Participants wear this like a badge, for 4 days after the study

  The first measurement will be performed in winter 2020, with a repeat measurement approximately 3 months later in spring 2020.

Secondary Outcomes (26)

• Anthropometrical measurements - weight

  One measurement at baseline

• Anthropometrical measurements - change in weight

  The first measurement will be performed in winter 2020, with a repeat measurement approximately 3 months later in spring 2020.

• Anthropometrical measurements - height

  One measurement at baseline

• Anthropometrical measurements - Hip circumference

  One measurement at baseline

• Anthropometrical measurements - waist circumference

  One measurement at baseline

Interventions

N/A - no intervention. Observational study. OTHER

N/A - no intervention. Observational study.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility based on gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is women aged over 18, who are not in menopause. Healthy women who have African-Caribbean ancestry, and have lived in the UK for more than 2 months are eligible.

You may qualify if:

• Women
• British African-Caribbean Self-reported Having African ancestral origin and migrated via the Caribbean islands, or having at least one parent with African ancestral origin that migrated via the Caribbean
• Living in England 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)
• BMI 18-30kg/m2

You may not qualify if:

• 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 commencing study or plans for a sun holiday for more than 4 weeks within the study period
• Women who take vitamin D or calcium supplements (or multivitamin supplements that contain these vitamins) - If potential participant agrees to stop supplement use to join the study, a wash-out period of 8 weeks prior to commencing the study is acceptable
• Living in England for less than 2 months

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

University of Surrey

Guildford, GU27XH, United Kingdom

RECRUITING

Related Publications (5)

• Natcen.ac.uk. (2018). NatCen Social Research. [online] Available at: http://www.natcen.ac.uk/news-media/press-releases/2018/january/natcen-and-mrc-epidemiology-unit-cambridge-to-deliver-national-diet-and-nutrition-survey/ [Accessed 16 July. 2019].

  BACKGROUND

• Sturges, M. & Cannell, JJ (2018). Meta-analysis questions relationship between vitamin D and bone health among the elderly. [online] The Vitamin D Council Blog & Newsletter, January 23, 2018 [Accessed 16 July. 2019].

  BACKGROUND

• Wall, BF, Haylock, R, Jansen, JTM, Hillier, MC, Hart, D, Shrimpton PC (2011). Radiation Risks from Medical X-ray Examinations as a Function of the Age and Sex of the Patient. [online] https://pdfs.semanticscholar.org/d90f/22c2c119c618c6822eb094087464e5ca3c4b.pdf [Accessed 7 October 2019)

  BACKGROUND

• Wilson LR, Tripkovic L, Hart KH, Lanham-New SA. Vitamin D deficiency as a public health issue: using vitamin D2 or vitamin D3 in future fortification strategies. Proc Nutr Soc. 2017 Aug;76(3):392-399. doi: 10.1017/S0029665117000349. Epub 2017 Mar 28.

  PMID: 28347378 BACKGROUND

• Libon F, Cavalier E, Nikkels AF. Skin color is relevant to vitamin D synthesis. Dermatology. 2013;227(3):250-4. doi: 10.1159/000354750. Epub 2013 Oct 17.

  PMID: 24134867 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A blood sample will be taken from participants and will include: * serum 25OHD, calcium and albumin, P1NP, CTX, lipid profile, micronutrient status * PTH plasma, blood glucose level * Whole Blood DNA

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 27, 2019
• Study Start: February 7, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Project data will be held for at least 6 years and all research data for at least 10 years in accordance with University policy and in accordance with the {UK} Data Protection Act (2018)
• Access Criteria: Anoymised data only. Data will be shared virtually with those in the research teams at partner universities.

Locations

GB (1)