None listed
Conditions
Interventions
Intervention1: Iron fortified infant cereal: 1. Fortified infant cereal, fortified with micronutrient and constituent with water
2. Daily two servings each of 25 gm of infant cereal reconstituted wit
Sponsors
Mr Marc Alder
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age at time of screening of Intervention group should be 6th month of life and Control group should be 12th month of life 2.Apparently healthy 3.Normal weight for age should be within greater or lesser than 2 SD of WHO growth curve 4.Breastfeeding (or formula feeding, or mixed feeding) is already complemented by other foods 5.Having obtained Parent or Legally Acceptable Representative Written Informed Consent
Exclusion criteria
Exclusion criteria: Any of the following criteria would render a subject ineligible for inclusion: 1.Chronic illness necessitating medical follow up 2.Acute ongoing or recent (last 2 weeks) illness necessitating medical follow up 3.Parasitic infection 4.Currently enrolled in a fortification program 5.Documented intolerance to gluten 6.Documented intolerance to lactose 7.Documented allergy to bovine milk proteins 8.Infants with Hemoglobin 10 mg/L 9.Caregivers who are not likely to comply with the study procedures 10.Caregivers that plan to move to another area during the next 6 months (only for the intervention group) 11.Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The iron status of infants, fed with iron fortified cereal, at 12 months of age will be higher or at least equal to that at baseline (6 months of age) or to that of the observational control group at 12 months of age.Timepoint: Baseline, 6 months age and 12 months age | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate change in total body iron stores To measure inflammatory status by evaluating C-Reactive protein (CRP) To evaluate various hematological parameters To access normal body development To evaluate health status of study subjects for safety assessment during conduct of study To assess dietary intake of subject To study feeding pattern, parent satisfaction & cost of illness To assess developmental status of subject Timepoint: Baseline, 6 months age and 12 months age | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed