Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy (HAART)
Brief Summary: This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes happens when people start HIV treatment. For this study, the following HIV treatment (or HAART) were provided in the form of a single tablet that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common for people who are taking HIV drugs for the first time. The risks seen with this HIV treatment are the same that you would encounter when taking these drugs outside of the study. The lists of risks of this HIV treatment are included in this document because the drugs are provided by the study, not because the drugs are being tested. The purpose of the study is only to look at the impact of high doses of vitamin D and calcium in preventing bone loss. There are no study objectives related to HIV treatment (EFV/FTC/TDF).


Options:
A: Arm Label: 1; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebos | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Behavioral: Diet, Behavioral: Exercise, Other: Placebos | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Behavioral: Diet, Behavioral: Exercise, Drug: Niacin, Other: Placebos | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Behavioral: Diet, Behavioral: Exercise, Drug: Fenofibrate, Other: Placebos | Arm Label: 5; Type: EXPERIMENTAL; Interventions: Behavioral: Diet, Behavioral: Exercise, Drug: Niacin, Drug: Fenofibrate | Intervention Type: BEHAVIORAL; Name: Diet; Assigned to Arm(s): 2, 3, 4, 5 | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): 2, 3, 4, 5 | Intervention Type: DRUG; Name: Niacin; Assigned to Arm(s): 3, 5 | Intervention Type: DRUG; Name: Fenofibrate; Assigned to Arm(s): 4, 5 | Intervention Type: OTHER; Name: Placebos; Assigned to Arm(s): 1, 2, 3, 4
B: 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
C: Arm Label: A: tenofovir/vitamin D; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D supplement | Arm Label: B: tenofovir/placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: C: no tenofovir/vitamin D; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D supplement | Arm Label: D: no tenofovir/placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D supplement; Assigned to Arm(s): A: tenofovir/vitamin D, C: no tenofovir/vitamin D | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): B: tenofovir/placebo, D: no tenofovir/placebo
D: Arm Label: Multiple RDA multivitamins; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Multivitamins (including B, C and E) | Arm Label: Single RDA Multivitamins; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Multivitamins B, C and E | Intervention Type: DIETARY_SUPPLEMENT; Name: Multivitamins (including B, C and E); Assigned to Arm(s): Multiple RDA multivitamins | Intervention Type: DIETARY_SUPPLEMENT; Name: Multivitamins B, C and E; Assigned to Arm(s): Single RDA Multivitamins

Answer: B