Vitamin D Deficiency
Conditions
Keywords
adolescents, minority
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.
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.
Interventions
DRUGVitamin D3
Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* age 13-20
Exclusion criteria
* currently receiving treatment for hypovitaminosis D * hepatic or renal disease * metabolic rickets * inability to complete the questionnaire
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL) | Baseline to 3 months |
Countries
United States
Participant flow
Recruitment details
Patients were recruited aged 13-20 years from the Adolescent Medicine and Pediatric Endocrinology practices at Children's Hospital at Montefiore.
Pre-assignment details
Of the 305 adolescents screened, only 203 met the inclusion criteria of being vitamin D deficient. Of the 203 adolescents identified with vitamin D deficiency, 20 were unable to be further contacted and randomized.
Participants by arm
| Arm | Count |
|---|---|
| Low Dose VItamin D3 1,000 IU
1 x day, 8 weeks
Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. | 61 |
| Weekly High Dose Vitamin D3 50,000 IU
1x week, 8 weeks
Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. | 59 |
| Daily High Dose Vitamin D3 5,000 IU
1x day, 8 weeks
Vitamin D3: Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up. | 63 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 19 | 20 | 22 |
Baseline characteristics
| Characteristic | Low Dose | Weekly High Dose | Daily High Dose | Total |
|---|---|---|---|---|
| Age, Continuous | 16.8 years STANDARD_DEVIATION 2.1 | 16.5 years STANDARD_DEVIATION 2.4 | 16.6 years STANDARD_DEVIATION 2.1 | 16.6 years STANDARD_DEVIATION 2.2 |
| Sex: Female, Male Female | 45 Participants | 45 Participants | 46 Participants | 136 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 17 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 59 | 0 / 63 |
| other Total, other adverse events | 0 / 61 | 0 / 59 | 0 / 63 |
| serious Total, serious adverse events | 0 / 61 | 0 / 59 | 0 / 63 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose | Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL) | 6.2 ng/mL | Standard Deviation 6.5 |
| Weekly High Dose | Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL) | 24.9 ng/mL | Standard Deviation 15.1 |
| Daily High Dose | Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL) | 21 ng/mL | Standard Deviation 15.2 |