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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT02548520

Collaborator

(none)

107

Enrollment

Location

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rickets Osteomalacia Osteoporosis	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 Design

Study Type:

Observational

Actual Enrollment :

107 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Vitamin D Status in the First 9 Months of Life

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Outcome Measures

Primary Outcome Measures

Prevalence in plasma 25OHD and parathyroid hormone at birth [at birth (baseline)]
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).

Secondary Outcome Measures

Prevalence in plasma 25OHD and parathyroid hormone at 4 months [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).
Prevalence in plasma 25OHD and parathyroid hormone at 9 months [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).

Other Outcome Measures

Questionnaire about lifestyle factors at birth [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).
Questionnaire about lifestyle factors at 4 months [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).
Questionnaire about lifestyle factors at 9 months [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).
peripheral Quantitative Computed Tomography i nine months old infants [at 9 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years to 41 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Internal Medicine and Endocrinology, Aarhus University Hospital	Aarhus	Central Denmark Region	Denmark	DK-8000

Sponsors and Collaborators

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