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Trial registered on ANZCTR


Registration number
ACTRN12611000108910
Ethics application status
Approved
Date submitted
21/01/2011
Date registered
1/02/2011
Date last updated
5/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The vitamin D and breast feeding study
Scientific title
Intermittent maternal cholecalciferol supplementation to prevent vitamin D deficiency in the breast feeding infant and lactating mother.
Secondary ID [1] 253108 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D Deficiency 258669 0
Condition category
Condition code
Diet and Nutrition 258816 258816 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 259216 259216 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two intervention groups will be used. Monthly maternal oral cholecalciferol 1) 50,000 IU or 2) 100,000 IU during 4 months of exclusive lactation. A third arm receiving only placebo will be used. The first dose will be given by 2 weeks postnatal age. Dosing will consist of monthly medication in blister packs of placebo/placebo, placebo/50,000IU Cholecalciferol or 50,000IU Cholecalciferol/50,000IU Cholecalciferol as appropriate.
Intervention code [1] 257631 0
Treatment: Drugs
Intervention code [2] 257866 0
Prevention
Comparator / control treatment
Placebo - identical to intervention oral capsule taken at same dosing interval as above (i.e. monthly for 4 months commencing within 2 weeks of birth).
Control group
Placebo

Outcomes
Primary outcome [1] 259680 0
Change in infant serum vitamin D (25OHD) level at 4 months
Timepoint [1] 259680 0
0, 4 months
Primary outcome [2] 261958 0
Change in maternal serum vitamin D (25OHD) level at 4 months
Timepoint [2] 261958 0
0, 2, 4 months
Secondary outcome [1] 266374 0
Between-treatment/placebo differences for changes in maternal bone turnover markers including serum analysis of Parathyroid hormone, Alkaline phosphatase, osteocalcin, 1-25 dihydroxyvitamin D, Calcium, Phosphate
Timepoint [1] 266374 0
0, 2, 4 months postnatal
Secondary outcome [2] 266375 0
Between-treatment/placebo differences for changes in infant bone turnover markers including serum analysis of Parathyroid hormone, Alkaline phosphatase, osteocalcin, 1-25 dihydroxyvitamin D, Calcium, Phosphate
Timepoint [2] 266375 0
0, 4 months

Eligibility
Key inclusion criteria
Healthy pregnant women intending to exclusively breast feed for at least 4 months.
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) unwilling to stop taking additional postnatal supplements that contain vitamin D 2) not intending to exclusively breast feed for at least 4 months, 3) delivery prior to 37 weeks gestation, 4) Low or elevated calcium levels at baseline or 5) not willing to take vitamin D supplementation, 6) Health conditions potentially affecting vitamin D metabolism e.g. on anticonvulsants, malabsorption problems, 7) Potential subjects will also be excluded if they are planning to travel to a sunny climate during the study period.

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)
Following delivery, breast feeding mothers will be randomly allocated to one of the three arms of the trial by independant pharmacy staff, not involved with recruitment. All will receive monthly medication in blister packs of placebo/placebo, placebo/50,000IU Cholecalciferol or or 50,000IU Cholecalciferol/50,000IU as appropriate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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] 3052 0
New Zealand
State/province [1] 3052 0
Otago

Funding & Sponsors
Funding source category [1] 258086 0
Charities/Societies/Foundations
Name [1] 258086 0
Healthcare Otago Charitable Trust
Address [1] 258086 0
HealthCare Otago Charitable Trust
Private Bag 1921
Dunedin 9016
Country [1] 258086 0
New Zealand
Funding source category [2] 258087 0
University
Name [2] 258087 0
University of Otago
Address [2] 258087 0
University of Otago
PO Box 56
Dunedin, 9054
Country [2] 258087 0
New Zealand
Primary sponsor type
University
Name
Dunedin School of Medicine
Address
University of Otago
PO Box 56
Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 257269 0
Hospital
Name [1] 257269 0
Southern District Health Board
Address [1] 257269 0
Dunedin Public Hospital
201 Great King Street
Private Bag 1921
Dunedin 9016
Country [1] 257269 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260074 0
Lower South Regional Ethics Committee
Ethics committee address [1] 260074 0
PO Box 5849
Dunedin 9016
Ethics committee country [1] 260074 0
New Zealand
Date submitted for ethics approval [1] 260074 0
05/02/2011
Approval date [1] 260074 0
09/05/2011
Ethics approval number [1] 260074 0

Summary
Brief summary
Vitamin D is essential for mineral balance of the skeleton. In children, deficiency classically causes Rickets, leading to bone thinning and malformation. Deficiency is also associated with low bone mineral density which has potential long-term implications. Vitamin D also plays a major role in the immune system.

Vitamin D is unique among vitamins as its main source is not dietary, but synthesis in the skin following exposure to UVB radiation, from sunlight. UVB radiation exposure varies based on latitude, skin colour, sunscreen use and clothing. Changes in human lifestyle including sun avoidance practices, indoor occupations and recreation, added to NZ’s geographical location at 35ºS to 47ºS, mean that children and adults cannot depend on adequate skin exposure to sunlight for vitamin D synthesis.

Dietary intake is a secondary source, but there is little in foods most humans normally ingest. As opposed to many countries NZ currently has no mandatory food supplementation. Compounding this, human milk, which is advocated as the ideal fluid source for infants, has been criticised as being generally low in vitamin D and this has led some to recommend universal supplementation for breast feeding infants.

One of the reasons breast milk is not a rich source of vitamin D is that many breast feeding mothers have low vitamin D status. Preliminary work from the United States suggests that daily supplementation of the breast feeding mother with high dose vitamin D can safely lead to improved vitamin D levels for both her and her nursing infant.

This suggests an attractive alternative to universal supplementation of breast fed infants. Supplementing infants via their mother’s breast milk supports current WHO recommendations on the importance of breast feeding and also avoids the issue of direct supplementation of exclusively breast-fed infants which is controversial and poorly complied with by families.

This study is powered to provide definitive data on clinically significant changes to baseline vitamin D levels for both the lactating mother and breast feeding infant during three arms of monthly treatment - 50000IU vitamin D3, 100000IU vitamin D3 or placebo . Results form this study will be used to inform public health policy regarding vitamin D supplementation during periods of exclusive lactation/breast feeding.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31926 0
Dr Benjamin John Wheeler
Address 31926 0
Department of Women’s and Children’s Health, Dunedin School of Medicine, University of Otago, PO Box 56 Dunedin, 9054
Country 31926 0
New Zealand
Phone 31926 0
+64 3 4740999
Fax 31926 0
Email 31926 0
ben.wheeler@otago.ac.nz
Contact person for public queries
Name 15173 0
Dr Dr Ben Wheeler
Address 15173 0
Department of Women’s and Children’s Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin, 9054
Country 15173 0
New Zealand
Phone 15173 0
+64 3 4740999
Fax 15173 0
+64 3 4747817
Email 15173 0
ben.wheeler@otago.ac.nz
Contact person for scientific queries
Name 6101 0
Dr Ben Wheeler
Address 6101 0
Department of Women’s and Children’s Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin, 9054
Country 6101 0
New Zealand
Phone 6101 0
+64 3 4740999
Fax 6101 0
+64 3 4747817
Email 6101 0
ben.wheeler@otago.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