NCT00267540

Brief Summary

Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13. More specifically the effects on the following parameters will be assessed:

  • Vitamin D metabolites.
  • Parathyroid hormone.
  • Bone turnover.
  • Bone mineral accretion.
  • Serum calcium and phosphate.
  • Renal handling of calcium and phosphate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Typical duration 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

Study Start

First participant enrolled

January 1, 2001

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
Last Updated

January 30, 2008

Status Verified

January 1, 2008

First QC Date

December 20, 2005

Last Update Submit

January 29, 2008

Conditions

Vitamin D Deficiency

Keywords

Vitamin Dadolescent girlsbone accretionbone turn overvitamin D statusVitamin D insufficiency in young girls

Outcome Measures

Primary Outcomes (3)

  • Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year.

  • Bone accretion measured by DXA. Measurement at baseline and after one year.

  • Bone turnover measured at baseline, half a year and one year

Interventions

cholecalciferol (D3) (vitamin)BEHAVIORAL

Eligibility Criteria

Age10 Years - 11 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Girls born in Denmark with Danish citizenship aged 10.0-11.0 years living in the municipals of Copenhagen and Frederiksberg

You may not qualify if:

  • Any chronical disease with influence on bone mass or turnover
  • Intake of drugs with influence on bone mass or turnover
  • Intake of calcium or vitamin D other than the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg, DK 1958, Denmark

Location

Related Publications (1)

  • Cashman KD, FitzGerald AP, Viljakainen HT, Jakobsen J, Michaelsen KF, Lamberg-Allardt C, Molgaard C. Estimation of the dietary requirement for vitamin D in healthy adolescent white girls. Am J Clin Nutr. 2011 Mar;93(3):549-55. doi: 10.3945/ajcn.110.006577. Epub 2011 Jan 26.

    PMID: 21270380DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

CholecalciferolVitamins

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Christian Mølgaard, MD, PhD

    The Royal Veterinary and Agricultural University, Frederiksberg, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 21, 2005

Study Start

January 1, 2001

Study Completion

December 1, 2003

Last Updated

January 30, 2008

Record last verified: 2008-01

Locations

DK(1)