Treatment Study of Vitamin D Deficiency in Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 13 - 20 |
| Updated: | 10/18/2018 |
| Start Date: | February 2013 |
| End Date: | July 2014 |
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
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.
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.
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.
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.
Inclusion Criteria:
- age 13-20
Exclusion Criteria:
- currently receiving treatment for hypovitaminosis D
- hepatic or renal disease
- metabolic rickets
- inability to complete the questionnaire
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