NCT01058720

Brief Summary

The study is designed to evaluate the increment of serum 25 (OH) vitamin D levels in normal weight adolescents following a 12-week supplementation with Vitamin D3 2000 IU/day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

January 27, 2010

Last Update Submit

December 30, 2015

Conditions

Vitamin D Deficiency

Keywords

Vitamin DSupplementationAdolescence

Outcome Measures

Primary Outcomes (1)

  • Increment in 25(OH)vitamin D level

    12 weeks

Secondary Outcomes (1)

  • Serum Calcium

    12 weeks

Study Arms (1)

Vitamin D3

EXPERIMENTAL

Patients would receive 2000 IU of vitamin D3 daily for 12 weeks

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

2000 IU orally once daily for 12 weeks

Vitamin D3

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects between ages 12 and 18 years with BMI between the 5th and the 85th percentile for age and gender.

You may not qualify if:

  • Subjects with 25 (OH)- D levels \>80 ng/mL
  • Serum calcium \>10.8 mg/dL
  • Serum phosphorus \> 5.5 mg/dl
  • Pregnancy or nursing
  • Current cancer
  • Patients on multivitamin supplementation
  • Dietary calcium intake exceeding 1500 mg/day
  • Hepatic or renal disorders
  • Type 1 or Type 2 diabetes mellitus
  • Those receiving insulin, metformin, or oral hypoglycemic medications
  • Malabsorption disorders (Celiac disease, Cystic fibrosis, Inflammatory bowel disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

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

  • Seema Kumar, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 27, 2010

First Posted

January 29, 2010

Study Start

December 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 1, 2016

Record last verified: 2015-12

Locations

US(1)