|  | Study period | |||
---|---|---|---|---|---|
 | Pre-randomization | Intervention | Post-intervention follow-up | Post-intervention follow-up | |
Time point | 1 weeks | 0 | 4 months | 4 months | 12 months |
Subjects | Screening Cohort N = 1500 | RCT subjects n = 150 | RCT subjects n = 150 | Â | Â |
INTERVENTIONS: | Â | Â | Â | Â | Â |
Intervention | Â | X | X | Â | Â |
Control | Â | X | X | Â | Â |
PROCEDURES: Informed consent | X | Â | Â | Â | Â |
Eligibility screen | X | Â | Â | Â | Â |
Randomization | Â | X | Â | Â | Â |
ASSESSMENTS: | Â | Â | Â | Â | Â |
TARGet Kids! Child and Family Questionnaire | X | Â | Â | Â | Â |
Laboratory measurements: Hemoglobin, serum ferritin, mean corpuscular volume (MCV), C-reactive protein (CRP) | X | Â | Â | X | X |
IBQ (12-17 months infants)/ECBQ (18-36 months children)/CBQ (37-72 months children)* | X | Â | Â | X | X |
Physical measurements: height and weight, waist circumference | X | Â | Â | X | X |
Mullen Scales of Early Learning (MSEL) | Â | X | Â | X | X |
4 month follow-up questionnaire | Â | Â | Â | X | Â |