Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Vitamin D and Calcium on Bone in Pediatric HIV
Brief Summary: We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations, is common in children and adolescents with HIV infection. To determine whether vitamin D and calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in HIV-infected children and adolescents, we propose a double-blind, randomized, placebo-controlled trial comparing supplementation with oral vitamin D and calcium to placebo.

The specific aims of this project are to:

1. Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in HIV-infected children.

   We hypothesize that BMC and BMD will increase to a greater extent in HIV-infected children who receive supplementation with vitamin D and calcium. This hypothesis will be tested by comparing changes in BMC and BMD, measured by dual energy x-ray absorptiometry (DXA), after one and two years of treatment in HIV-infected children and adolescents receiving vitamin D and calcium supplementation compared to those receiving placebo.
2. Determine the effect of HIV infection and vitamin D and calcium supplementation on indices of mineral metabolism and markers of bone turnover.

   We hypothesize that indices of mineral metabolism and markers of bone formation and resorption will return toward normal in HIV-infected children and adolescents who are randomized to receive vitamin D and calcium supplementation. We will test these hypotheses by comparing longitudinal changes in indices of mineral metabolism and bone turnover markers in HIV-infected children and adolescents receiving vitamin D and calcium supplement versus those receiving placebo
3. Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and adolescents receiving HAART.

We hypothesize that vitamin D stores, as assessed by serum 25-hydroxyvitamin D levels, are an important determinant of bone mass in HIV-infected children and adolescents receiving HAART. We will test this hypothesis by evaluating whether measurements of bone mass are associated with vitamin D stores, as measured by serum 25-hydroxyvitamin D levels and other indices of mineral metabolism, in treated HAART-treated HIV-infected children and adolescents.


Options:
A: Arm Label: Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate; Type: EXPERIMENTAL; Interventions: Drug: EFV/FTC/TDF, Drug: Calcium Carbonate, Drug: Vitamin D3 | Arm Label: Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo; Type: EXPERIMENTAL; Interventions: Drug: EFV/FTC/TDF, Drug: Placebo for calcium carbonate, Drug: Placebo for vitamin D3 | Intervention Type: DRUG; Name: EFV/FTC/TDF; Assigned to Arm(s): Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate, Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo | Intervention Type: DRUG; Name: Calcium Carbonate; Assigned to Arm(s): Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate | Intervention Type: DRUG; Name: Vitamin D3; Assigned to Arm(s): Arm A: EFV/FTC/TDF plus vitamin D3 and calcium carbonate | Intervention Type: DRUG; Name: Placebo for calcium carbonate; Assigned to Arm(s): Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo | Intervention Type: DRUG; Name: Placebo for vitamin D3; Assigned to Arm(s): Arm B: EFV/FTC/TDF plus vitamin D placebo and calcium placebo
B: Arm Label: 7000IU/day; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Vitamin D3 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): 7000IU/day | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: A; Type: EXPERIMENTAL; Interventions: Dietary Supplement: cholecalciferol plus calcium carbonate | Arm Label: B; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: cholecalciferol plus calcium carbonate | Intervention Type: DIETARY_SUPPLEMENT; Name: cholecalciferol plus calcium carbonate; Assigned to Arm(s): A, B
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: Multivitamins; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Multivitamins | Intervention Type: DIETARY_SUPPLEMENT; Name: Multivitamins; Assigned to Arm(s): Multivitamins | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo

Answer: C