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

Vitamin D Status in the First 9 Months of Life

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Rickets; Osteomalacia
• Intervention / Treatment: Other: Blood and breastmilk samples

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.

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus, Central Denmark Region, Denmark, DK-8000
      • Department of Internal Medicine and Endocrinology, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy pregnant Caucasian women with a normal pregnancy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence in plasma 25OHD and parathyroid hormone at birth	For determination of plasma 25OHD and plasma parathyroid hormone concentrations, the investigators sampled cord blood at baseline. Furthermore the investigators collected maternal blood at 2 weeks after birth (baseline).	at birth (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence in plasma 25OHD and parathyroid hormone at 4 months	For determination of plasma 25OHD and plasma parathyroid hormone concentrations, the investigators sampled maternal and infants blood samples at 4 months (1. follow-up).	at 4 months
Prevalence in plasma 25OHD and parathyroid hormone at 9 months	For determination of plasma 25OHD and plasma parathyroid hormone concentrations, the investigators sampled maternal and infants blood samples at 9 months (2. follow-up).	at 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire about lifestyle factors at birth	At birth the investigators collected, via self reported focused questionnaires, data regarding breastfeeding status, use of vitamin D supplements among children and their mothers, use of calcium supplements and dietary calcium intake (milk and cheese consumption) and other lifestyle factors, including physical activity (baseline).	at birth
Questionnaire about lifestyle factors at 4 months	At 4 months the investigators collected, via self reported focused questionnaires, data regarding breastfeeding status, use of vitamin D supplements among children and their mothers, use of calcium supplements and dietary calcium intake (milk and cheese consumption) and other lifestyle factors, including physical activity (1. follow up).	at 4 months
Questionnaire about lifestyle factors at 9 months	At 9 months visit the investigators collected, via self reported focused questionnaires, data regarding breastfeeding status, use of vitamin D supplements among children and their mothers, use of calcium supplements and dietary calcium intake (milk and cheese consumption) and other lifestyle factors, including physical activity (2. follow up).	at 9 months
peripheral Quantitative Computed Tomography i nine months old infants	At 9 months the investigators investigated 1) whether there was a correlation between maternal vitamin D status or calcium intake (i.e. diet and supplements) and bone mass and structure as measured by peripheral quantitative computed tomography in the infants 9 months after birth, and 2) gender differences in measured peripheral quantitative computed tomography variables. Furthermore the investigators evaluated 3) the feasibility of performing peripheral quantitative computed tomography scans on newborn infants in terms of assessing the precision of peripheral quantitative computed tomography scan.	at 9 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Susanna við Streym, PhD, Department of Internal Medicine and Endocrinology, Aarhus University Hospital; Study Director: Lars Rejnmark, Professor, Department of Internal Medicine and Endocrinology, Aarhus University Hospital; Study Chair: Peter Vestergaard, Professor, The Department of Endocrinology, Aalborg University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Estimate): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 11, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Musculoskeletal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Bone Diseases; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Vitamin D Deficiency; Osteoporosis; Rickets; Osteomalacia
• Other Study ID Numbers: M-2007-0255