None listed
Conditions
Interventions
Intervention1: MNP Vit Min Pre Little Bits: IP will be consumed daily.
Micronutrient sprinkler powder containing iron to assess safety and performance in children.
Control Intervention1: Under Nationa
Sponsors
Amway India Enterprises Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject (boy or girl) aged 3.0-5.9 years and residing in India 2. For subjects with ages 3.0-5.9 years both inclusive, WHO MGRS 2006 weight-for-age z-scores between -1 and -2 3. The subject to remain in the same locality for the duration of the study (up to 6 months) 4. Subject with good general and mental health in the investigatorâ??s opinion 5. Subjectâ??s parent/ LAR understand and are willing, able and likely to comply with all study procedures and restrictions 6. Subjectâ??s parent/LAR is willing to accommodate frequent home visits/ telephonic communication by the study personnel. 7. Subjectâ??s parent/LAR are willing to sign the ICF. 8. Hemoglobin (Hb) levels less than 10 g/dL, and children who started complementary foods
Exclusion criteria
Exclusion criteria: 1.Subject with recent history within 3 months prior to signing ICF of surgery, serious infections or injuries 2. Subject with known or suspected intolerance or hypersensitivity to the study product or closely related compounds or any of their stated ingredients 3. Subject who needs to be fed with a special diet OR who needs to be fed with a diet which is different from that advised by the study center nutritionist OR current taking a nutritional supplement (MVM with average consumption of greater than or equal to 10%) in the past 3 months prior to screening. 4. The subject on restrictions that prevent adherence to the diet plan, which is advised by the study center nutritionist during dietary advice. 5. Subject with known food allergies as reported by parent or LAR. 6. Subject currently participating, or has participated in a drug or device study or a nutritional program run by the local government or NGO within a period of 30 days prior to screening. 7. Child-in-care CiC- A child who has been placed under the control or protection of an agency, organization, institution, or any entity by the courts, the government, or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed LAR. 8. Subject related to an employee of the sponsor or the study site staff. 9. Hb concentrations less than or equal to 10.0g per dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine changes in % HemoglobinTimepoint: Changes in % Hemoglobin will be measured at baseline, 4 weeks (Visit 3), 13 weeks(Visit 4), 26 weeks (Visit 5). | — |
Secondary
| Measure | Time frame |
|---|---|
| Behavioral changes (using questionnaires) â?? activeness, irritability, communication, interest in learning, physical activity, mood, sleep etc.Timepoint: Throughout the study;Overall health improvement (malnutrition status) as per clinician evaluation and guardian/parent perceptionTimepoint: Throughout the study;To determine incidence of AE and SAE.Timepoint: Throughout the study;To study Anthropometry (Height and weight for age, upper arm circumference)Timepoint: Before and after dosing. | — |
Countries
India
Contacts
Public ContactAparna Damle
Amway India Enterprises Pvt Ltd
Outcome results
None listed