Vitamin D deficiency Nutritional, Metabolic, Endocrine Vitamin D deficiency
Conditions
Interventions
Current interventions as of 13/07/2015:
1. The study will aim to recruit 265 caucasian women and 90 south-asian women who will be randomly assigned to the intervention groups
2. Participants will rece
looking specifically at the genes that are activated by vitamin D
7. To be followed up at 6 weeks and 12 weeks
Previous interventions:
1. The study will aim to recruit 348 caucasian women and 114 so
Sponsors
University of Surrey (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female, aged 20-64 years 2. Caucasian ethnic origin or partly-veiled women of South Asian (i.e. India, Pakistan, Bangladesh) or Arabian ethic origin 3. Body Mass Index 18-30 kg/m2 4. Pre-menopausal OR five years post-menopause 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Currently receiving treatment for medical conditions likely to affect vitamin D metabolism 2. Regular use of sunbeds 3. Having a sun holiday one month prior to commencing the trial or plans for a sun holiday within the study period 4. Use of vitamin supplements containing vitamin D 5. Consumption of alcohol above recommended levels (>14units per week) 6. Those following a weightreducing diet or under dietary restriction (except vegetarianism) 7. Known intolerance/allergy to the constituent ingredients of the intervention products 8. Clinically significant haematological abnormalities other than mild anaemia (Hb>10.0g/dl) 9. Active malignancy 10. Postmenopause less than five years 11. Pregnant or planning a pregnancy during the study period 12. Breastfeeding mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum 25-hydroxyvitamin D at baseline, week 6 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/07/2015: 1. 1,25 dihydroxyvitamin D at baseline, week 6, week 12 (for 48 participants, high and low responders) 2. Blood pressure at baseline, week 6, week 12 3. Bone mineral density at baseline 4. C-terminal telopeptide (CTX) at baseline, week 6, week 12 5. Dietary intake at baseline and week 12 6. Fasting glucose and insulin at baseline, week 6, week 12 7. Full blood count at baseline only 8. Height, weight, waist circumference at baseline, week 6, week 12 9. Kidney function (U&Es) at baseline only 10. Leukocyte RNA analysis at baseline, week 6, week 12 (for 48 participants, high and low responders) 11. Liver function (LFTs) at baseline only 12. Non-Esterified Fatty Acid and Triacyglcerol at baseline, week 6, week 12 14. 13. Parathyroid hormone at baseline, week 6, week 12 14. Serum calcium, corrected calcium and albumin at baseline, week 6, week 12 15. Single-nucleotide polymorphism analysis (SNP) at baseline only 16. Total and HDL Cholesterol at baseline, week 6, week 12 17. UV exposure at baseline and week 12 18. Vitamin D binding protein at baseline, week 6, week 12 (for 48 participants, high and low responders) 19. Vitamin D metabolites at baseline, week 6, week 12 (for 48 participants, high and low responders) 20. Vitamin D receptor at baseline, week 6, week 12 (for 48 participants, high and low responders) Previous secondary outcome measures: 1. 1,25 dihydroxyvitamin D at baseline, week 6, week 12 2. Blood pressure at baseline, week 6, week 12 3. Bone mineral density at baseline, week 6, week 12 4. C-terminal telopeptide (CTX) at baseline, week 6, week 12 5. CYP27A1 at baseline, week 6, week 12 6. Dietary intake at baseline and week 12 7. Fasting glucose and insulin at baseline, week 6, week 12 8. Full blood count at baseline only 9. Height, weight, waist circumference at baseline, week 6, week 12 10. Kidney function (U&Es) at baseline only 11. Leukocyte RNA analysis at baseline, week 6, week 12 12. Liver func | — |
Countries
United Kingdom
Outcome results
None listed