Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants
Brief Summary: The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they have designed a study to determine how much dietary vitamin D is needed to optimize health in infants. This is important since many infants are born with vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is unclear and recent research suggests that vitamin D status very early in life has long lasting effects on bone mass and other health issues. Therefore, in a group of healthy infants, this research team will test which dosage of vitamin D is needed to achieve optimal vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D and bone status in blood and also general health. The infants will all be breastfed and begin the study at about 2 weeks of age. At 3 months intervals over the first year of life, each infant will be measured for growth, duration of breastfeeding and supplement use plus have a bone density scan to determine changes in bone growth. The data will be helpful to guide health care professionals in providing the best care possible for their infants. It will also be important to the health of populations since dietary recommendations for vitamin D are used to guide fortification of foods and development of evidence based policy around nutrient recommendations and their implementation.


Options:
A: Arm Label: 10 mcg Vitamin D3; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 10 mcg Vitamin D3 | Arm Label: 20 mcg Vitamin D3; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 20 mcg Vitamin D3 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: 10 mcg Vitamin D3; Assigned to Arm(s): 10 mcg Vitamin D3 | Intervention Type: DIETARY_SUPPLEMENT; Name: 20 mcg Vitamin D3; Assigned to Arm(s): 20 mcg Vitamin D3 | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Sustained; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cholecalciferol | Arm Label: Diet-Limited; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Cholecalciferol | Intervention Type: DIETARY_SUPPLEMENT; Name: Cholecalciferol; Assigned to Arm(s): Diet-Limited | Intervention Type: DRUG; Name: Cholecalciferol; Assigned to Arm(s): Sustained
C: Arm Label: 400 IU Vitamin D3; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Cholecalciferol (D3) or ergocalciferol (D2) | Arm Label: 400 IU Vitamin D2; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Cholecalciferol (D3) or ergocalciferol (D2) | Intervention Type: DIETARY_SUPPLEMENT; Name: Cholecalciferol (D3) or ergocalciferol (D2); Assigned to Arm(s): 400 IU Vitamin D2, 400 IU Vitamin D3
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Vitamin D | Intervention Type: DRUG; Name: Vitamin D; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Vitamin D; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Vitamin D; Assigned to Arm(s): 3

Answer: D