Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Absorption of Zinc From Mixed Diets Containing Conventional Bangladeshi Rice, Zinc-biofortified Bangladeshi Rice, or Conventional Bangladeshi Rice With Added Zinc Among Young Children in a Peri-urban Community
Brief Summary: a. To measure the amount of zinc absorbed from ZnBfR compared with the amount absorbed from CR and from CR fortified with added zinc, using the triple stable isotope tracer ratio technique in young children.

Methods:

Investigators will measure the amount of zinc absorbed from ZnBfR compared to that absorbed from a conventional Bangladeshi rice (Diet-CR) (control). They will also compare the zinc absorption from ZnBfR with that from zinc-fortified conventional rice (Diet-CR+Z). The study will be a cross-over, randomized, controlled clinical study. Forty-four children aged 36-59 mo of either sex will be recruited from the same community as mentioned before, and participants will be individually randomized, in equal numbers, to one of the two comparison groups, A and B. During an initial one-day acclimatization period, the participants will receive the conventional rice-based diet three times a day, to confirm that participants will accept the study diets and adhere to the study procedures. On study days 2 and 4, in comparison group A, participants will receive either the Diet-ZBfR or Diet-CR based on the random assignments, and participants will receive Diet-CR or Diet ZBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4), Likewise, in comparison group B, the participants will receive either Diet-ZBfR or Diet-CR+Z on days 2 and 4 based on the random assignments, and participants will receive Diet-CR+Z or the Diet-ZBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4). Investigators will use zinc stable isotope tracer techniques to measure the fractional absorption of zinc, in which tracer:tracee ratios will be measured in spot urine samples following administration of an intravenously administered tracer (68Zn) and one of two oral tracers (70Zn, 67Zn) provided with test meals over a four-day period.

Outcome measures/variables:

Intake of total dietary zinc (TDZ) and phytate for each subject will be calculated during the clinical study. Fractional absorption of zinc (FAZ) will be determined from the isotopic ratios obtained in urine samples using the following equation, which shows, as an example, the calculation that will be used for zinc absorption from the diet traced with 67Zn:

FAZ = 67Zn tracer:tracee ratio / 68Zn tracer:tracee ratio \* (68Zn dose given IV / 67Zn dose given orally)

Total absorbed zinc (TAZ) for each child will be calculated as follows:

TAZ (mg/d) = TDZ (mg/d) \* FAZ


Options:
A: Arm Label: Zinc-fortified bread (10 mg zinc/d); Type: EXPERIMENTAL; Interventions: Dietary Supplement: Zinc-fortified bread, Dietary Supplement: Placebo supplement | Arm Label: Zinc fortified bread (20 mg zinc/d); Type: EXPERIMENTAL; Interventions: Dietary Supplement: Zinc-fortified bread, Dietary Supplement: Placebo supplement | Arm Label: Zinc supplemented group; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Zinc supplement, Dietary Supplement: Non-fortified bread | Arm Label: Non-fortified group; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Non-fortified bread, Dietary Supplement: Placebo supplement | Intervention Type: DIETARY_SUPPLEMENT; Name: Zinc-fortified bread; Assigned to Arm(s): Zinc fortified bread (20 mg zinc/d), Zinc-fortified bread (10 mg zinc/d) | Intervention Type: DIETARY_SUPPLEMENT; Name: Zinc supplement; Assigned to Arm(s): Zinc supplemented group | Intervention Type: DIETARY_SUPPLEMENT; Name: Non-fortified bread; Assigned to Arm(s): Non-fortified group, Zinc supplemented group | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo supplement; Assigned to Arm(s): Non-fortified group, Zinc fortified bread (20 mg zinc/d), Zinc-fortified bread (10 mg zinc/d)
B: 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
C: 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
D: 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

Answer: C