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Trial registered on ANZCTR


Registration number
ACTRN12613000383763
Ethics application status
Approved
Date submitted
4/04/2013
Date registered
10/04/2013
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Monthly 50,000 IU or 100,000 IU Vitamin D Supplements on Vitamin D Levels in Pre-menopausal Middle Eastern Women Living in Auckland - Middle Eastern Women's Health Study-Phase II
Scientific title
The Effect of Monthly 50,000 IU or 100,000 IU Vitamin D Supplements on Serum 25(OH)D Concentrations in Pre-menopausal Middle Eastern Women Living in Auckland
Secondary ID [1] 282239 0
Nil
Universal Trial Number (UTN)
U1111-1141-4144
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency, in Middle Eastern women living in Auckland 288757 0
Condition category
Condition code
Diet and Nutrition 289114 289114 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286849 0
Treatment: Other
Intervention code [2] 286854 0
Prevention
Comparator / control treatment
Placebo: a tablet identical in form to the active dose, but with no active ingredients.
Active control: a vitamin D tablet containing 50,000 IU cholecalciferol
Control group
Dose comparison

Outcomes
Primary outcome [1] 289225 0
Vitamin D levels assessed by measuring serum 25(OH)D concentrations
Timepoint [1] 289225 0
At baseline, 3 months and 6 months
Secondary outcome [1] 302073 0
Parathyroid Hormone (PTH) levels assessed by measuring serum PTH concentrations










Timepoint [1] 302073 0
At baseline, 3 months and 6 months

Eligibility
Key inclusion criteria
Healthy women, being in pre-menopausal stage, and being of Middle Eastern origin or both parents born in the Middle Eastern countries
Minimum age
20 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key 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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women will be invited to participate in the study by leaflets and invitations. Leaflets will be distributed in a number of venues around Auckland. A number of presentations will be given to social and community gathering on different occasions. The researcher then will contact respondents and interview them about exclusion and inclusion criteria.
Participants who meet the eligibility criteria will sign informed consent forms and will be randomly assigned to 1 of 2 monthly vitamin doses or placebo.
The researcher will dispense study medication to the participants. A third party (not involved with the research group will place the allocated treatments into a pill dispenser containing 6 compartments, one for each month and label them with letters A to C, the study number, the date dispensed and participant's identification number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization scheme will be generated using the Web site Randomization.com (http://www.randomization.com). A statistician off-site, will use sequence generation to allocate treatment A to C (50,000 IU, 100,000 IU or placebo) to each participant enrolled. A third party then will place the allocated treatments into pill dispensers with the study number, the date dispensed and participant's identification number on them. All of this will be done independently to the researchers, to ensure double-blind status is maintained. At the final stage, the researcher will dispense study medication to the participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4969 0
New Zealand
State/province [1] 4969 0
Auckland

Funding & Sponsors
Funding source category [1] 287004 0
University
Name [1] 287004 0
Institute of Food, Nutrition and Human Health
Address [1] 287004 0
Massey University
Private Bag 102904
North Shore City
Auckland
0745
Country [1] 287004 0
New Zealand
Primary sponsor type
Individual
Name
Mrs Hajar Mazahery
Address
Institute of Food, Nutrition and Human Health
Massey University
Private Bag 102904
North Shore City
Auckland
0745
Country
New Zealand
Secondary sponsor category [1] 285791 0
Individual
Name [1] 285791 0
Dr Pamela von Hurst
Address [1] 285791 0
Institute of Food, Nutrition and Human Health
Massey University
Private Bag 102904
North Shore City
Auckland
0745
Country [1] 285791 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289047 0
Health and Disability Ethics Committee
Ethics committee address [1] 289047 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington, 6011
Ethics committee country [1] 289047 0
New Zealand
Date submitted for ethics approval [1] 289047 0
15/04/2013
Approval date [1] 289047 0
21/05/2013
Ethics approval number [1] 289047 0
13/STH/40

Summary
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.
Trial website
Trial related presentations / publications
Mazahery, H., W. Stonehouse, and P.R. von Hurst, The effect of monthly 50,000 IU or 100,000 IU vitamin D supplements on vitamin D status in premenopausal Middle Eastern women living in Auckland. Eur J Clin Nutr, 2015. 69(3): p. 367-72.
Public notes

Contacts
Principal investigator
Name 38970 0
Mrs Hajar Mazahery
Address 38970 0
Institute of Food, Nutrition and Human Health
Massey University
Private Bag 102904
North Shore City
Auckland
0745
New Zealand
Country 38970 0
New Zealand
Phone 38970 0
+64-9-4473538
Fax 38970 0
Email 38970 0
h.mazahery@hotmail.com
Contact person for public queries
Name 38971 0
Mrs Hajar Mazahery
Address 38971 0
Institute of Food, Nutrition and Human Health
Massey University
Private Bag 102904
North Shore City
Auckland
0745
New Zealand
Country 38971 0
New Zealand
Phone 38971 0
+64-9-4473538
Fax 38971 0
Email 38971 0
h.mazahery@hotmail.com
Contact person for scientific queries
Name 38972 0
Dr Pamela von Hurst
Address 38972 0
Institute of Food, Nutrition and Human Health
Massey University
Private Bag 102904
North Shore City
Auckland
0745
New Zealand
Country 38972 0
New Zealand
Phone 38972 0
+64-9-414 0800 ext 41205
Fax 38972 0
Email 38972 0
P.R.vonHurst@massey.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary