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Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents

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Mayo Clinic

Status and phase

Completed
Phase 4

Conditions

Vitamin D Deficiency

Treatments

Dietary Supplement: Vitamin D3

Study type

Interventional

Funder types

Other

Identifiers

NCT01058720
09-004969

Details and patient eligibility

About

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.

Full description

Twenty normal weight adolescents between ages 12-18 that are age and gender would receive vitamin D3 supplementation at a dose of 2000 IU/day. Levels of 25(OH)vitamin D would be measured at baseline and after 12 weeks.Relationship between 25 OH vitamin D levels and other demographic variables will be assessed.The primary endpoint in this study is the 25 OH Vitamin D level at 12 weeks.

Enrollment

20 patients

Sex

All

Ages

12 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Vitamin D3
Experimental group
Description:
Patients would receive 2000 IU of vitamin D3 daily for 12 weeks
Treatment:
Dietary Supplement: Vitamin D3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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