Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prevention of Post-Cardiac Surgery Vitamin D Deficiency in Children With Congenital Heart Disease: A Pilot Dose Evaluation Randomized Controlled Trial
Brief Summary: Our research group has shown that almost all children with congenital heart disease (CHD) are vitamin D deficient following heart surgery. This work strongly suggests that the vitamin D intake presently recommended for healthy children, and also given to children with CHD, is inadequate to prevent vitamin D deficiency following surgery. Unfortunately, there have been no studies investigating any other vitamin D dose in children with heart disease. Recently, a higher dose of vitamin D intake has been approved (by the Institute of Medicine and Health Canada) and recent work on healthy children has shown it to be safe. The objective of this study is to determine whether this recently approved higher dose of vitamin D can safely reduce the number of children who are vitamin D deficient following surgery. This dose evaluation study will also evaluate whether it is possible to perform a large study (across Canada) to determine whether vitamin D supplementation can improve outcomes following surgery. It is hypothesized that a daily high dose vitamin D regimen, modeled on the Institute of Medicine daily upper tolerable intake level (UL), will significantly reduce vitamin D deficiency following CHD surgery, when compared with usual intake.


Options:
A: Arm Label: Usual care group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: High Dose Group; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Cholecalciferol | Intervention Type: DIETARY_SUPPLEMENT; Name: Cholecalciferol; Assigned to Arm(s): High Dose Group
B: Arm Label: 2000 IU per day vitamin D; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D3 - Cholecalciferol 2000 IU | Arm Label: 400 IU per day vitamin D; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vitamin D - Cholecalciferol 400 IU | Intervention Type: DRUG; Name: Vitamin D - Cholecalciferol 400 IU; Assigned to Arm(s): 400 IU per day vitamin D | Intervention Type: DRUG; Name: Vitamin D3 - Cholecalciferol 2000 IU; Assigned to Arm(s): 2000 IU per day vitamin D
C: Arm Label: Oral Vitamin D--200 IU/day; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Cholecalciferol | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Arm Label: Oral Vitamin D--800 IU/day; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Cholecalciferol | Intervention Type: DIETARY_SUPPLEMENT; Name: Cholecalciferol; Assigned to Arm(s): Oral Vitamin D--200 IU/day | Intervention Type: DIETARY_SUPPLEMENT; Name: Cholecalciferol; Assigned to Arm(s): Oral Vitamin D--800 IU/day | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: RUTF with Vitamin D; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D, Dietary Supplement: Ready to Use Therapeutic Food (RUTF) | Arm Label: RUTF with Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Ready to Use Therapeutic Food (RUTF) | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D; Assigned to Arm(s): RUTF with Vitamin D | Intervention Type: DIETARY_SUPPLEMENT; Name: Ready to Use Therapeutic Food (RUTF); Assigned to Arm(s): RUTF with Placebo, RUTF with Vitamin D

Answer: A