NCT02145195

Brief Summary

The main purpose of this study is to investigate whether and in which doses vitamin D intake is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children during wintertime.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

May 20, 2014

Last Update Submit

March 24, 2015

Conditions

Vitamin D Deficiency

Keywords

Vitamin DChildrenSupplementsCardiometabolic markersImmune defenseBone turnoverMuscle strength

Outcome Measures

Primary Outcomes (1)

  • Change in vitamin D status

    Serum concentrations of total 25-hydroxyvitamin D \[25(OH)D\]

    Baseline and 20 weeks

Secondary Outcomes (3)

  • Change in anthropometric measurements

    Baseline and 20 weeks

  • Change in body composition

    Baseline and 20 weeks

  • Serum calcium

    Baseline and 20 weeks

Other Outcomes (4)

  • Change in cardio-metabolic markers

    Baseline and 20 weeks

  • Change in markers of immune defense

    Baseline and 20 weeks

  • Change in muscle strength

    Baseline and 20 weeks

  • +1 more other outcomes

Study Arms (3)

Vitamin D (10 microgram/day)

EXPERIMENTAL

Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.

Dietary Supplement: Vitamin D3 (cholecalciferol)

Vitamin D (20 microgram/day)

EXPERIMENTAL

Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.

Dietary Supplement: Vitamin D3 (cholecalciferol)

Placebo control

PLACEBO COMPARATOR

Tablets with 0 microgram vitamin D daily for 20 weeks.

Interventions

Vitamin D3 (cholecalciferol)DIETARY_SUPPLEMENT
Vitamin D (10 microgram/day)Vitamin D (20 microgram/day)

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years at the start of the intervention
  • healthy
  • of white, Danish/European origin
  • children must be Danish-speaking
  • parents must read and speak Danish
  • not planning a winter vacation south of a latitude of 51°North (corresponding to Surrey, England)

You may not qualify if:

  • diseases that may interfere with vitamin D or calcium metabolism
  • intake of medication known to affect vitamin D or calcium metabolism
  • use of vitamin D containing supplements ≥ 4 days/week the last 8 weeks before intervention start and use of any vitamin D containing supplements the last 4 weeks before intervention start
  • concomitant participation in other studies involving dietary supplements or blood sampling
  • serum calcium \> 2.7 mmol/L at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, 1958, Denmark

Location

Related Publications (4)

  • Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Sun behaviour and physical activity associated with autumn vitamin D status in 4-8-year-old Danish children. Public Health Nutr. 2018 Dec;21(17):3158-3167. doi: 10.1017/S1368980018002094. Epub 2018 Sep 7.

    PMID: 30189911DERIVED

  • Hauger H, Molgaard C, Mortensen C, Ritz C, Frokiaer H, Smith TJ, Hart K, Lanham-New SA, Damsgaard CT. Winter Cholecalciferol Supplementation at 55 degrees N Has No Effect on Markers of Cardiometabolic Risk in Healthy Children Aged 4-8 Years. J Nutr. 2018 Aug 1;148(8):1261-1268. doi: 10.1093/jn/nxy080.

    PMID: 29917069DERIVED

  • Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Winter vitamin D3 supplementation does not increase muscle strength, but modulates the IGF-axis in young children. Eur J Nutr. 2019 Apr;58(3):1183-1192. doi: 10.1007/s00394-018-1637-x. Epub 2018 Feb 15.

    PMID: 29450728DERIVED

  • Mortensen C, Damsgaard CT, Hauger H, Ritz C, Lanham-New SA, Smith TJ, Hennessy A, Dowling K, Cashman KD, Kiely M, Molgaard C. Estimation of the dietary requirement for vitamin D in white children aged 4-8 y: a randomized, controlled, dose-response trial. Am J Clin Nutr. 2016 Nov;104(5):1310-1317. doi: 10.3945/ajcn.116.136697. Epub 2016 Oct 12.

    PMID: 27733403DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Christian Mølgaard, PhD, MD

    Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

DK(1)