Treatment of vitamin D insufficiency in children and adolescents with inflammatory bowel disease: a randomized clinical trial comparing three regimens.
What this study found
The more effective regimens for raising serum 25OHD over 6 weeks were vitamin D3 2,000 IU daily and vitamin D2 50,000 IU weekly; both outperformed vitamin D2 2,000 IU daily. Mean 25OHD increased by 9.3 ± 1.8 ng/mL with daily D2, 16.4 ± 2.0 ng/mL with daily D3, and 25.4 ± 2.5 ng/mL with weekly D2, with follow-up levels of 25.7 ± 2.2, 31.5 ± 1.9, and 40.8 ± 2.6 ng/mL, respectively. Vitamin D3 produced a greater rise than vitamin D2 at the same 2,000 IU daily dose, and 95% of participants in the daily D3 and weekly D2 arms exceeded 20 ng/mL versus 75% in the daily D2 arm. All regimens were safe…
- Study & population
- Randomized clinical trial in children and adolescents with inflammatory bowel disease and vitamin D insufficiency (serum 25OHD ≤ 20 ng/mL).
- Intervention
- Three oral vitamin D repletion regimens were compared over 6 weeks: vitamin D2 2,000 IU daily, vitamin D3 2,000 IU daily, and vitamin D2 50,000 IU weekly.
- Key limitation
- The trial was short and relatively small, with only 20 to 21 completers per arm, which limits precision for comparative efficacy and safety.
View source
Open PDFOriginal abstract
CONTEXT Vitamin D insufficiency [serum 25-hydroxyvitamin D (25OHD) concentration less than 20 ng/ml] is prevalent among children with inflammatory bowel disease (IBD), and its treatment has not been studied. OBJECTIVE The aim of this study was to compare the efficacy and safety of three vitamin D repletion regimens. DESIGN AND SETTING We conducted a randomized, controlled clinical trial from November 2007 to June 2010 at the Clinical and Translational Study Unit of Children's Hospital Boston. The study was not blinded to participants and investigators. PATIENTS Eligibility criteria included diagnosis of IBD, age 5-21, and serum 25OHD concentration below 20 ng/ml. Seventy-one patients enrolled, 61 completed the trial, and two withdrew due to adverse events. INTERVENTION Patients received orally for 6 wk: vitamin D(2), 2,000 IU daily (arm A, control); vitamin D(3), 2,000 IU daily (arm B); vitamin D(2), 50,000 IU weekly (arm C); and an age-appropriate calcium supplement. MAIN OUTCOME MEASURE We measured the change in serum 25OHD concentration (Δ25OHD) (ng/ml). Secondary outcomes included change in serum intact PTH concentration (ΔPTH) (pg/ml) and the adverse event occurrence rate. RESULTS After 6 wk, Δ25OHD ± se was: 9.3 ± 1.8 (arm A); 16.4 ± 2.0 (arm B); 25.4 ± 2.5 (arm C); P (A vs. C) = 0.0004; P (A vs. B) = 0.03. ΔPTH ± SE was -5.6 ± 5.5 (arm A); -0.1 ± 4.2 (arm B); -4.4 ± 3.9 (arm C); P = 0.57. No participant experienced hypercalcemia or hyperphosphatemia, and the prevalence of hypercalciuria did not differ among arms at follow-up. CONCLUSIONS Oral doses of 2,000 IU vitamin D(3) daily and 50,000 IU vitamin D(2) weekly for 6 wk are superior to 2,000 IU vitamin D(2) daily for 6 wk in raising serum 25OHD concentration and are well-tolerated among children and adolescents with IBD. The change in serum PTH concentration did not differ among arms.