Maternal and Infant Vitamin Status During the First Nine Months of Infant Life

NCT ID: NCT02548520

Last Updated: 2015-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 107 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-03-31

Brief Summary

In this study the investigators wanted to assess vitamin D status and possible consequences of low plasma 25-hydroxyvitamin D levels in a population of healthy mothers and their infants, in the community of Aarhus, Denmark.

Detailed Description

Danish people living at northern latitudes (56°N), often with overcast and foggy weather and few sunshine hours are at increased risk of vitamin D insufficiency. Although vitamin D is obtainable from fortified food and oily fish, the major source is the dermal synthesis of the vitamin D through exposure to solar ultraviolet light.

In the 19th century rickets was endemic in northern Europe, and many children developed rickets, a severe bone-deforming disease. Encouragement of sensible sun exposure, supplementation with cod liver oil and fortification of milk with vitamin D, resulted in an almost complete eradication of rickets by the end of the 19th century. At present vitamin D deficiency seems again to be more widespread. The classical outcomes of severe vitamin D deficiency are rickets in growing individuals and osteomalacia in adults. Low vitamin D status also relates to low bone density and increased risk of osteoporotic fractures. Although the incidence of rickets has declined over the last decades, cases attributable to inadequate vitamin D intake and low exposure to sunlight continue to be reported, and maternal vitamin D status may have permanent effects on newborns' health. Pregnant women, newborns, breastfed children, and lactating women are at a high risk of vitamin D deficiency, especially during winter and early spring.

Since fetal plasma 25-hydroxyvitamin D (25OHD) depends on maternal 25OHD, fetal vitamin D status may show seasonal changes parallel to those observed in the mothers. To prevent rickets and vitamin D deficiency in infants, most Western countries, including Denmark, recommend a daily maternal intake during pregnancy and lactation of 10 μg and that breastfed children are given a supplement of 10 μg of vitamin D/day. Despite these recommendations, approximately one third of Danish pregnant and lactating women have vitamin D insufficiency. However, childhood rickets is nowadays rare in Denmark, although it still exists especially among immigrants and mothers with prolonged lactation. Accordingly, in 2010, the Danish National Board of Health extended the recommendations for vitamin D supplementation to the first two years of life.

Conditions

Rickets; Osteomalacia; Osteoporosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Blood and breastmilk samples

The investigators collected maternal and infants blood samples from birth, and 4 and 9 months forward, including breastmilk from the mothers at all visits

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy pregnant Caucasian women aged 24-41 years,
• A normal pregnancy giving birth between 38-42 gestational weeks.

Exclusion Criteria

• Chronic diseases,
• Other ethnic origin than Caucasian, and
• Alcohol or drug abuse.

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanna við Streym, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine and Endocrinology, Aarhus University Hospital

Lars Rejnmark, Professor

Role: STUDY_DIRECTOR

Department of Internal Medicine and Endocrinology, Aarhus University Hospital

Peter Vestergaard, Professor

Role: STUDY_CHAIR

The Department of Endocrinology, Aalborg University Hospital

Locations

Department of Internal Medicine and Endocrinology, Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Countries

Denmark

References

Vieth Streym S, Kristine Moller U, Rejnmark L, Heickendorff L, Mosekilde L, Vestergaard P. Maternal and infant vitamin D status during the first 9 months of infant life-a cohort study. Eur J Clin Nutr. 2013 Oct;67(10):1022-8. doi: 10.1038/ejcn.2013.152. Epub 2013 Sep 4.

Reference Type: BACKGROUND

PMID: 24002039 (View on PubMed)

vieth Streym S, Hojskov CS, Moller UK, Heickendorff L, Vestergaard P, Mosekilde L, Rejnmark L. Vitamin D content in human breast milk: a 9-mo follow-up study. Am J Clin Nutr. 2016 Jan;103(1):107-14. doi: 10.3945/ajcn.115.115105. Epub 2015 Dec 16.

Reference Type: DERIVED

PMID: 26675779 (View on PubMed)

Other Identifiers

M-2007-0255

Identifier Type: -

Identifier Source: org_study_id