Skip to main content
OpenTrials
Completed

NCT Number: NCT01784029

Treatment Study of Vitamin D Deficiency in Adolescents

To compare the efficacy of two high dose vitamin D3 regimens (5,000 IU daily vs. 50,000 IU weekly) used clinically for the treatment of vitamin D deficiency versus a low dose of vitamin D3 used for supplementation (1,000 IU daily) in a clinical sample of predominantly Hispanic and black adolescents with vitamin D deficiency [25(OH)D level <20 ng/ml] by assessing change in 25(OH)D levels before and after 8 weeks of treatment.

To compare the effects of vitamin D repletion [25(OH)D level >20 ng/mL] on selected musculoskeletal, cardiometabolic and immune markers in predominantly Hispanic and black adolescents with vitamin D deficiency [25(OH)D level < 20 ng/mL].

Hypothesis 1: Increase in vitamin D level will be associated with improvement in musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.

Completed

Looking for future studies?

Notify Me

Key information

Age range

13 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital at Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

Vitamin D is an essential nutrient and pro-hormone that has garnered widespread attention over the past decade for both its known and theorized health benefits. Patients, clinicians and researchers have all been alerted to the increasing prevalence of vitamin D deficiency (defined as level of 25(OH)D <20 ng/mL) and the significance of the extra-skeletal health effects of vitamin D. Aside from the skeletal impacts of Vitamin D, there has been recent evidence about potential health benefits of vitamin D related to the multiple extra-skeletal roles of this hormone. In fact, vitamin D receptors are found in many organs including brain, heart, skin, small intestine, gonads, prostate and breast as well in almost all nucleated cells including osteoblasts, activated T and B-lymphocytes, and B islet cells. Studies in children and adolescents as well as in adults show associations of vitamin D deficiency with cardiovascular risk factors, musculoskeletal health, asthma, and autoimmune diseases.

While Vitamin D deficiency is quite prevalent, adolescents who are obese or who are darker skinned are consistently shown to have higher rates of vitamin D deficiency than lean and lighter skinned adolescents. Treatment of vitamin D deficiency and maintenance of sufficient levels in adolescents are largely under-studied leaving patients and clinicians without clear evidence-based guidelines to follow.

The goal of this study is to compare the efficacy of different treatment regimens for vitamin D deficiency in our population of predominantly minority adolescents and to examine the effect of correction of vitamin D deficiency on selected extra-skeletal targets of vitamin D action including musculoskeletal, cardiometabolic, and immune function.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 13-20

Exclusion criteria

  • currently receiving treatment for hypovitaminosis D
  • hepatic or renal disease
  • metabolic rickets
  • inability to complete the questionnaire

Treatment and study plan

Vitamin D3

Drug

Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.

Other names: cholecalciferol

Primary outcomes

  1. Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL)

    Time frame: Baseline to 3 months

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Comparison of Two Standard High-dose Treatment Regimens for Vitamin D Deficiency in Minority Adolescents: Associations of Vitamin D Repletion With Changes in Markers of Musculoskeletal, Cardiometabolic, and Immune Function

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2013
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.