Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Consumption of Micronutrient Fortified Yoghurt on Biochemical Markers, Cognitive Development, Morbidity and Physical Growth Among 6-9 Years School Going Children in Bangladesh - A Double Masked, Randomized Trial With a Concurrent Matched Control
Brief Summary: To evaluate the efficacy of consumption of yoghurt fortified with 30% recommended dietary allowance (RDA) of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year in comparison to same yoghurt without fortification for change in mean levels and proportion deficient for markers of status of Iron (Hemoglobin, Serum ferritin, Serum transferrin, ZnPP), Vitamin A (Plasma retinol levels), Iodine (Urinary iodine levels), Zinc (Plasma zinc), and copper (Plasma copper levels, sub sample of children); improvement in cognitive development, reduction in episodes/days of illnesses (diarrhea, pneumonia, febrile illness), hospitalizations and morbidity causing absenteeism from school and improvement in growth. Additionally to evaluate the efficacy of consumption of fortified and non fortified yoghurt (plain yoghurt) for a period of 12 months in comparison to pure control that do not receive any intervention in the improvement in cognitive development and physical growth. The main objective is to evaluate the impact of addition of micronutrients to Yoghurt and can be best addressed by RCT. The effect of taking yoghurt per se cannot be blinded so for that the investigators have included a concurrent control.

Hypothesis: Consumption of fortified yoghurt with 30% RDA of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year will improve the micronutrient status indicators, cognitive development, and growth and reduce morbidity of children.


Options:
A: Arm Label: Zinc sulphate; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Zinc sulfate as dietary supplementation | Arm Label: Zinc Amino Acid Chelate; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Zinc amino acid chelate as dietary supplementation | Arm Label: Milk without fortification; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Milk without fortification without zinc | Intervention Type: DIETARY_SUPPLEMENT; Name: Zinc sulfate as dietary supplementation; Assigned to Arm(s): Zinc sulphate | Intervention Type: DIETARY_SUPPLEMENT; Name: Zinc amino acid chelate as dietary supplementation; Assigned to Arm(s): Zinc Amino Acid Chelate | Intervention Type: DIETARY_SUPPLEMENT; Name: Milk without fortification without zinc; Assigned to Arm(s): Milk without fortification
B: Arm Label: Group A; Type: OTHER; Interventions: Other: Diet-ZnBfR, Other: Diet- CR | Arm Label: Group B; Type: OTHER; Interventions: Other: Diet-ZnBfR, Other: CR + Zn | Intervention Type: OTHER; Name: Diet-ZnBfR; Assigned to Arm(s): Group A | Intervention Type: OTHER; Name: Diet- CR; Assigned to Arm(s): Group A | Intervention Type: OTHER; Name: Diet-ZnBfR; Assigned to Arm(s): Group B | Intervention Type: OTHER; Name: CR + Zn; Assigned to Arm(s): Group B
C: Arm Label: Fortified Yoghurt; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Fortified Yoghurt | Arm Label: Yoghurt; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Yoghurt | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Fortified Yoghurt; Assigned to Arm(s): Fortified Yoghurt | Intervention Type: DIETARY_SUPPLEMENT; Name: Yoghurt; Assigned to Arm(s): Yoghurt
D: Intervention Type: DRUG; Name: Micronutrient (Zinc and Iron) fortification; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Pre and Probiotic fortification; Assigned to Arm(s): N/A

Answer: C