The vitamin D and breast feeding study

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; Diet and Nutrition - Other diet and nutrition disorders; Reproductive Health and Childbirth - Breast feeding

• Registration Number: ACTRN12611000108910
• Lead Sponsor: Dunedin School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

Healthy pregnant women intending to exclusively breast feed for at least 4 months.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in infant serum vitamin D (25OHD) level at 4 months[0, 4 months];Change in maternal serum vitamin D (25OHD) level at 4 months[0, 2, 4 months]

Secondary Outcome Measures

Name	Time	Method
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[0, 2, 4 months postnatal];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[0, 4 months]