NCT03381378

Brief Summary

This study will encompass an analysis of an eventual association between vitamin D status (maternal during pregnancy, at birth or at 5 years) and hand grip strength at 5 years in children from Odense Child Cohort. Odense Child Cohort is a large-scale, prospective, population-based, follow-up study. Mothers and their children born from January 2010 to December 2012 and resident in the Municipality of Odense, Denmark, are followed from early pregnancy up to adulthood. Data is obtained from questionnaires and medical records and venous blood samples were drawn and stored at a biological bank. Low muscle strength in children has been linked to adiposity, cardiovascular disease and metabolic risk factors and low muscle strength in adolescence has been shown to be a risk factor of early adulthood mortality. There are not many studies on muscle strength in small children. There is some evidence of vitamin D concentrations in the blood having a positive correlation to upper body muscle strength in adolescent girls. Hypovitaminosis D defined as serum 25-hydroxyvitamin D \<50nmol/L was evident in 27,8% of the pregnant women and 47,7% of the new-born children in Odense Child Cohort. Animal studies have shown an effect of vitamin D on regulation of muscle function and development. Studies on humans adults have shown that vitamin D deficiency can lead to myopathy. Myopathy in children as a result of hypovitaminosis D is not well-studied. Given the high prevalence of hypovitaminosis D, mild or severe vitamin D-associated myopathy may be prevalent in preschool children. The objectives of this study are 1) to create reference values and determine predictors of hand grip strength at five years, 2) to analyze the associations between vitamin D at different time points and hand grip strength at 5 years.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
881

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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

January 4, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

1.5 years

First QC Date

December 18, 2017

Last Update Submit

December 22, 2017

Conditions

Keywords

Vitamin Ds-25-hydroxyvitamin Dhand grip strengthmyopathymuscle

Outcome Measures

Primary Outcomes (1)

  • Hand Grip Strength at 5 years

    DHD-1 Digital Hand Dynamometer is used to measure 5-year-old children's hand grip strength. According to standard protocol the child is instructed to hold the dynamometer and the handle is adjusted to the child's hand. The child must be able to press the handle using the whole hand and not just the finger joints. The child must sit with a straight back and feet on the ground. The arm must not be supported by the hip, the elbow must be flexed to 90 degrees and the hand must be in the natural position. The child is instructed to press as hard as possible but in a slow movement to avoid sudden changes in position that might affect the results. Each measurement is approximately 5 seconds long with 1 minute break in between measuring the right and left hand interchangeably. Three measurements of each hand are taken starting with the right hand. If the last measure is the highest, a fourth measurement is taken and a fifth and last measurement is taken if the fourth is the highest.

    Examination within a week of 5 year birthday. 3-5 measurements with a duration of 5 seconds each of each hand.

Eligibility Criteria

Age5 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This study was conducted using data from the Odense Child Cohort. Mothers and their children born from January 2010 to December 2012 and resident in the Municipality of Odense, Denmark, were followed from early pregnancy up to five years at present. Approximately 2500 children were included.

You may qualify if:

  • year-old children participating in Odense Child Cohort.

You may not qualify if:

  • Multiple and/or preterm birth (gestational age (GA) \<259 days)
  • Chronic disease
  • No available hand grip data at five years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Stark T, Walker B, Phillips JK, Fejer R, Beck R. Hand-held dynamometry correlation with the gold standard isokinetic dynamometry: a systematic review. PM R. 2011 May;3(5):472-9. doi: 10.1016/j.pmrj.2010.10.025.

    PMID: 21570036BACKGROUND
  • Andersen LB, Abrahamsen B, Dalgard C, Kyhl HB, Beck-Nielsen SS, Frost-Nielsen M, Jorgensen 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.

    PMID: 23305099BACKGROUND
  • Lykkedegn S, Beck-Nielsen SS, Sorensen GL, Andersen LB, Fruekilde PBN, Nielsen J, Kyhl HB, Joergensen JS, Husby S, Christesen HT. Vitamin D supplementation, cord 25-hydroxyvitamin D and birth weight: Findings from the Odense Child Cohort. Clin Nutr. 2017 Dec;36(6):1621-1627. doi: 10.1016/j.clnu.2016.10.008. Epub 2016 Oct 27.

    PMID: 27817876BACKGROUND
  • Kyhl HB, Jensen TK, Barington T, Buhl S, Norberg LA, Jorgensen 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.

    PMID: 25756293BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples.

MeSH Terms

Conditions

Vitamin D DeficiencyMuscular Diseases

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Professor, MD, PhD

Study Record Dates

First Submitted

December 18, 2017

First Posted

December 22, 2017

Study Start

January 4, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

December 26, 2017

Record last verified: 2017-12