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Completed

NCT Number: NCT02548520

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

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Key information

Age range

24 year–41 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Internal Medicine and Endocrinology, Aarhus University Hospital

Aarhus, Central Jutland, DK-8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood and breastmilk samples

Other

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

Primary outcomes

  1. Prevalence in plasma 25OHD and parathyroid hormone at birth

    Time frame: 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 outcomes

  1. Prevalence in plasma 25OHD and parathyroid hormone at 4 months

    Time frame: 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).

  2. Prevalence in plasma 25OHD and parathyroid hormone at 9 months

    Time frame: 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 outcomes

  1. Questionnaire about lifestyle factors at birth

    Time frame: 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).

  2. Questionnaire about lifestyle factors at 4 months

    Time frame: 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).

  3. Questionnaire about lifestyle factors at 9 months

    Time frame: 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).

  4. peripheral Quantitative Computed Tomography i nine months old infants

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Vitamin D Status in the First 9 Months of Life

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Sep 14, 2015
Registry last updated
Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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