ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vitamin D Deficiency

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Reproductive Health and Childbirth

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]

Treatment: Drugs

Intervention code [2]

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]

Change in infant serum vitamin D (25OHD) level at 4 months

Timepoint [1]

0, 4 months

Primary outcome [2]

Change in maternal serum vitamin D (25OHD) level at 4 months

Timepoint [2]

0, 2, 4 months

Secondary outcome [1]

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]

0, 2, 4 months postnatal

Secondary outcome [2]

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]

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

Sex

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

1/04/2011

Actual

18/08/2011

Date of last participant enrolment

Anticipated

Actual

9/09/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

105

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Healthcare Otago Charitable Trust

Address [1]

HealthCare Otago Charitable Trust
Private Bag 1921
Dunedin 9016

Country [1]

New Zealand

Funding source category [2]

University

Name [2]

University of Otago

Address [2]

University of Otago
PO Box 56
Dunedin, 9054

Country [2]

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]

Hospital

Name [1]

Southern District Health Board

Address [1]

Dunedin Public Hospital
201 Great King Street
Private Bag 1921
Dunedin 9016

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Lower South Regional Ethics Committee

Ethics committee address [1]

PO Box 5849
Dunedin 9016

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

05/02/2011

Approval date [1]

09/05/2011

Ethics approval number [1]

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

Dr Benjamin John Wheeler

Address

Department of Women’s and Children’s Health, Dunedin School of Medicine, University of Otago, PO Box 56 Dunedin, 9054

Country

New Zealand

Phone

+64 3 4740999

Fax

[email protected]

Contact person for public queries

Name

Dr Ben Wheeler

Address

Department of Women’s and Children’s Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin, 9054

Country

New Zealand

Phone

+64 3 4740999

Fax

+64 3 4747817

[email protected]

Contact person for scientific queries

Name

Ben Wheeler

Address

Department of Women’s and Children’s Health
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin, 9054

Country

New Zealand

Phone

+64 3 4740999

Fax

+64 3 4747817

[email protected]

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	High-dose monthly maternal cholecalciferol supplementation during breastfeeding affects maternal and infant vitamin D status at 5 months postpartum: A randomized controlled trial.	2016	https://dx.doi.org/10.3945/jn.116.236679

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically