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Treatment Study of Vitamin D Deficiency in Adolescents

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ClinicalTrials.gov Identifier: NCT01784029
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Susan Coupey, Montefiore Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D3 Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Dose

VItamin D3 1,000 IU

1 x day, 8 weeks

Drug: Vitamin D3
Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Other Name: cholecalciferol

Experimental: Weekly High Dose

Vitamin D3 50,000 IU

1x week, 8 weeks

Drug: Vitamin D3
Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Other Name: cholecalciferol

Experimental: Daily High Dose

Vitamin D3 5,000 IU

1x day, 8 weeks

Drug: Vitamin D3
Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Other Name: cholecalciferol




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 13-20

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784029


Locations
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United States, New York
Children's Hospital at Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Susan M Coupey, MD Children's Hospital at Montefiore

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Susan Coupey, Chief, Adolescent Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01784029     History of Changes
Other Study ID Numbers: 12-09-345
First Posted: February 5, 2013    Key Record Dates
Results First Posted: October 16, 2018
Last Update Posted: October 16, 2018
Last Verified: September 2018
Keywords provided by Susan Coupey, Montefiore Medical Center:
adolescents
minority
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents