NCT02548520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

September 9, 2015

Last Update Submit

September 11, 2015

Conditions

RicketsOsteomalaciaOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Prevalence in plasma 25OHD and parathyroid hormone at 4 months

    at 4 months

  • Prevalence in plasma 25OHD and parathyroid hormone at 9 months

    at 9 months

Other Outcomes (4)

  • Questionnaire about lifestyle factors at birth

    at birth

  • Questionnaire about lifestyle factors at 4 months

    at 4 months

  • Questionnaire about lifestyle factors at 9 months

    at 9 months

  • +1 more other outcomes

Interventions

Blood and breastmilk samplesOTHER

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

Eligibility Criteria

Age24 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy pregnant Caucasian women with a normal pregnancy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine and Endocrinology, Aarhus University Hospital

Aarhus, Central Jutland, DK-8000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 24002039BACKGROUND

  • 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.

    PMID: 26675779DERIVED

MeSH Terms

Conditions

RicketsOsteomalaciaOsteoporosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Susanna við Streym, PhD

    Department of Internal Medicine and Endocrinology, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Lars Rejnmark, Professor

    Department of Internal Medicine and Endocrinology, Aarhus University Hospital

    STUDY DIRECTOR

  • Peter Vestergaard, Professor

    The Department of Endocrinology, Aalborg University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 14, 2015

Study Start

October 1, 2008

Primary Completion

July 1, 2011

Study Completion

March 1, 2012

Last Updated

September 14, 2015

Record last verified: 2015-09

Locations

DK(1)