None listed
Conditions
Brief summary
We know that potential consequences of vitamin D deficiency extend beyond bone health. Vitamin D deficiency is implicated in some diseases such as CVD, type 2 diabetes and depression. We previously found a disturbingly high prevalence of vitamin D deficiency/insufficiency in Middle Eastern women living in Auckland, despite some women using prescribed vitamin D supplements (50,000 IU/month). In this survey, 100% of women had low vitamin D concentrations with 75% being deficient.The adequate dose for improving vitamin D status of this population to at least 50 nmol/L (the current minimum for adequacy) is unknown. The aim of this study is to investigate the adequacy of supplementation with monthly 50,000 IU and 100,000 IU vitamin D3 for 6 months in increasing serum 25(OH)D concentrations greater than or equal to 50 nmol/L in Middle Eastern pre-menopausal women living in Auckland, and to investigate the effect of supplementation with these dosages for 6 months on Parathyroid Hormone (PTH) concentrations. Sixty-six pre-menopausal women of Middle Eastern origin, living in Auckland, will be recruited. Participants will randomly receive monthly 50,000 IU, 100,000 IU or placebo for 6 months. Blood samples will be tested for serum 25(OH)D, calcium, and PTH concentrations at baseline, 3-months, and 6-months. The change in serum 25(OH)D and PTH concentrations in response to vitamin D supplementation will be assessed.
Interventions
Oral Vitamin D supplementation (Arm 1, 50,000 IU; or Arm 2, 100,000 IU cholecalciferol) or placebo taken once a month over 6 months starting in the winter. A duration of 6 months has been chosen as no difference has been seen in incremental increase in serum 25(OH)D concentrations between 6 and 12 months of supplementation with vitamin D. At the 3 and 6 months follow ups, adherence will be calculated by counting the not empty compartments.
A placebo has been included in this study to determine
Oral Vitamin D supplementation (Arm 1, 50,000 IU; or Arm 2, 100,000 IU cholecalciferol) or placebo taken once a month over 6 months starting in the winter. A duration of 6 months has been chosen as no difference has been seen in incremental increase in serum 25(OH)D concentrations between 6 and 12 months of supplementation with vitamin D. At the 3 and 6 months follow ups, adherence will be calculated by counting the not empty compartments. A placebo has been included in this study to determine the seasonal effect.
Sponsors
Mrs Hajar Mazahery
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy women, being in pre-menopausal stage, and being of Middle Eastern origin or both parents born in the Middle Eastern countries
Exclusion criteria
Having illnesses such as digestive disorders, kidney diseases, and liver diseases or taking medications such as glucocorticoids and anti-epileptic medicines, having hypercalcaemia, hypercalciuria, sarcoidosis, or renal osteodystrophy with hyperphosphatemia, having major systemic illnesses such as atherosclerosis or cardiac function impairment, having bleeding disorders or taking blood thinning medications, and/or treatment with vitamin D within the last 6 months (other than multivitamins).
Outcome results
None listed