ANZCTR - Registration

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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]

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

Condition category

Condition code

Diet and Nutrition

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]

Treatment: Other

Intervention code [2]

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]

Vitamin D levels assessed by measuring serum 25(OH)D concentrations

Timepoint [1]

At baseline, 3 months and 6 months

Secondary outcome [1]

Parathyroid Hormone (PTH) levels assessed by measuring serum PTH concentrations

Timepoint [1]

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

Sex

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

1/06/2013

Actual

1/06/2013

Date of last participant enrolment

Anticipated

1/09/2013

Actual

1/08/2013

Date of last data collection

Anticipated

Actual

1/02/2014

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

Institute of Food, Nutrition and Human Health

Address [1]

Massey University
Private Bag 102904
North Shore City
Auckland
0745

Country [1]

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]

Individual

Name [1]

Dr Pamela von Hurst

Address [1]

Institute of Food, Nutrition and Human Health
Massey University
Private Bag 102904
North Shore City
Auckland
0745

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington, 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

15/04/2013

Approval date [1]

21/05/2013

Ethics approval number [1]

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

Mrs Hajar Mazahery

Address

Institute of Food, Nutrition and Human Health
Massey University
Private Bag 102904
North Shore City
Auckland
0745
New Zealand

Country

New Zealand

Phone

+64-9-4473538

Fax

h.mazahery@hotmail.com

Contact person for public queries

Name

Hajar Mazahery

Address

Institute of Food, Nutrition and Human Health
Massey University
Private Bag 102904
North Shore City
Auckland
0745
New Zealand

Country

New Zealand

Phone

+64-9-4473538

Fax

h.mazahery@hotmail.com

Contact person for scientific queries

Name

Pamela von Hurst

Address

Institute of Food, Nutrition and Human Health
Massey University
Private Bag 102904
North Shore City
Auckland
0745
New Zealand

Country

New Zealand

Phone

+64-9-414 0800 ext 41205

Fax

P.R.vonHurst@massey.ac.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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