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

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ClinicalTrials.gov Identifier: NCT02548520
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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
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 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 : October 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones


Intervention Details:
  • Other: 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


Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   24 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy pregnant Caucasian women with a normal pregnancy
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548520


Locations
Denmark
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02548520     History of Changes
Other Study ID Numbers: M-2007-0255
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Osteoporosis
Rickets
Osteomalacia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders