The Vitamin D and Fetal Bone Length Study (VITFBL)

Bone Development Clinical Trial

Official title:

Decreased Femoral Bone Length by Fetal Ultrasound in Pregnant Women With Low Serum 25-hydroxyvitamin D: An Odense Child Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02439229
• Other study ID #: VITFBL
• Status: Active, not recruiting
• Phase: N/A
• First received: May 6, 2015
• Last updated: May 6, 2015
• Start date: January 2010
• Est. completion date: December 2031

Study information

• Verified date: May 2015
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Danish Data Protection Agency: Denmark
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The Vitamin D and fetal bone length study:

Vitamin D and its association to bone length in midterm pregnancy.

Description:

Overall:

The Odense Child Cohort Study (OCC) is a population-based cohort study, comprising pregnant women recruited between January 1st 2010 and December 31st 2012. All women who were pregnant in the municipality of Odense during this time were eligible for participation, and 6,707 women were approached directly with recruitment material.

The study complied with the Helsinki declaration and was approved by the Regional Scientific Ethical Committee for Southern Denmark, no. S-20090130. All participants gave informed consent. From a population base of 6,707 pregnant women, 2,874 (42.9%) enrolled in the OCC up to December 31st, 2012. The children will be followed until 18 years of age.

Serum samples were taken in early pregnancy (GA 2-25 weeks), late pregnancy (GA 26-30 weeks), maternal serum and cord blood at birth, and from the children along with general examinations at ages 3 months, 1 year, 3 years.

Questionnaires were completed by the families in early pregnancy, late pregnancy, after birth, and at the times of clinical examination of the children.

Register data on health variables were further available from the Danish registries.

Objective:

The Vitamin D and bone length Study examines the relationship between the biomarker 25(OH)D in maternal serum and the length of the fetal femur and humerus bone at mid term pregnancy.

Method:

25(OH)D analysis: Serum was stored at -80º Celsius until analysis, which was performed by liquid chromatography mass spectrometry (LC-MS/MS). Triple deuterium marked 25(OH)vitamin D3 was added to serum samples as internal standard and deproteinized with ZnSO4 in methanol, centrifuged at 2750 g for 10 minutes, and 100 μl was injected on the TurboFlow column (Thermo Scientific) on the LC-MS/MS. The LC-MS/MS consisted of a Thermo Scientific TLX1 system connected to a Thermo Scientific Vantage TSQ. 25(OH)D2 and 25(OH)D3 were concentrated on a Thermo Scientific Cyclone P 50 x 1.0 mm column and back-flushed on the analytical column, Phenomenex Gemini C18 50 x 3.0 mm and eluted from the analytical column by a gradient. Mobile phases were A: 10 mM NH4Ac in water and B: 10 mM NH4Ac in methanol. Human serum was spiked with appropriate amounts of 25(OH)D2 and 25(OH)D3 in order to produce six point calibration curves (weighed 1/x2) and 3 levels of QC samples (low, mid, high). The method was calibrated against NIST standard 972.25 The C3 epimer of D3 was detected along with D3 and the two were not distinguishable from one another. Lowest detectable concentrations were 0.15 nM for both D2 and D3. Values of D2 and D3 were only considered if above 6.5 nM.

The Vitamin D and bone length study:

Vitamin D and bone length in mid term pregnancy.

• In 986 serum samples collected in early pregnancy, the levels of serum 25(OH)D were investigated by LC-MS/. Questionnaire and medical file information was used to determine the factors which were influential on 25(OH)D levels and bone length in mid term pregnancy by multiple linear regression.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2874
• Est. completion date: December 2031
• Est. primary completion date: December 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant and residing in the municipality of Odense during 2010-2012

Exclusion Criteria:

• Not residing in Odense, leaving the municipality

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Development

Locations

Country	Name	City	State
Denmark	HCA Research, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

Andersen LB, Abrahamsen B, Dalgård C, Kyhl HB, Beck-Nielsen SS, Frost-Nielsen M, Jørgensen JS, Barington T, Christesen HT. Parity and tanned white skin as novel predictors of vitamin D status in early pregnancy: a population-based cohort study. Clin Endocrinol (Oxf). 2013 Sep;79(3):333-41. doi: 10.1111/cen.12147. Epub 2013 Jul 2. — View Citation

Christesen HT, Andersen LB. Reply to: 'vitamin D deficiency during pregnancy: confronting the issues'. Clin Endocrinol (Oxf). 2014 Jul;81(1):155-6. doi: 10.1111/cen.12328. Epub 2013 Oct 15. — View Citation

Christesen HT, Elvander C, Lamont RF, Jørgensen JS. The impact of vitamin D in pregnancy on extraskeletal health in children: a systematic review. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1368-80. doi: 10.1111/aogs.12006. Review. — View Citation

Christesen HT, Falkenberg T, Lamont RF, Jørgensen JS. The impact of vitamin D on pregnancy: a systematic review. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1357-67. doi: 10.1111/aogs.12000. Epub 2012 Oct 17. Review. — View Citation

Galthen-Sørensen M, Andersen LB, Sperling L, Christesen HT. Maternal 25-hydroxyvitamin D level and fetal bone growth assessed by ultrasound: a systematic review. Ultrasound Obstet Gynecol. 2014 Dec;44(6):633-40. doi: 10.1002/uog.13431. Review. — View Citation

Kyhl HB, Jensen TK, Barington T, Buhl S, Norberg LA, Jørgensen JS, Jensen DF, Christesen HT, Lamont RF, Husby S. The Odense Child Cohort: aims, design, and cohort profile. Paediatr Perinat Epidemiol. 2015 May;29(3):250-8. doi: 10.1111/ppe.12183. Epub 2015 Mar 10. — View Citation

Lykkedegn S, Sorensen GL, Beck-Nielsen SS, Christesen HT. The impact of vitamin D on fetal and neonatal lung maturation. A systematic review. Am J Physiol Lung Cell Mol Physiol. 2015 Apr 1;308(7):L587-602. doi: 10.1152/ajplung.00117.2014. Epub 2015 Jan 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femur length	Size of femur bone length assessed by ultrasound.	Outcome is assessed in gestational week 15+0 to 26+0.	No