Health Condition 1: E639- Nutritional deficiency, unspecified
Conditions
Interventions
Intervention1: Oral nutritional supplement (Pediasure) and Dietary counselling: Dosage Form: To prepare a 45.5 g serving, 1 product sachet should be completely added to 190 mL of water to make a 225ml
Sponsors
Abbott Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply: 1. Subject (male or female) aged 3.0-6.9 years, and residing in India 2. Subject to remain in the same locality for the duration of the study (up to 6 months) 3. Subject has a Height for age less than 25th percentile according to current WHO Growth Charts (WHO Growth Chart 2007) 4. Subject has a weight for height less than 25th percentile according to current WHO Growth Charts (WHO Growth Chart 2007) 5. Subject is able to consume foods and beverages orally 6. Child is a picky eater, defined as meeting at least two of the following criteria. A child, who a. eats only a limited number of foods b.is unwilling to try new foods c. refuses to eat vegetables and or foods from other food groups d. shows strong food likes and dislikes 16 e. has behaviors that disrupt mealtime 7. Child is a habitual milk drinker at least 1 glass (approx. 200ml) of milk daily. 8. Subject with good general and mental health in the investigator’s opinion 9. Subject’s parent or LAR understand and are willing, able and likely to comply with all study procedures and restrictions 10. Subject’s parent or LAR are willing to accommodate frequent home visits or telephonic communication by the study personnel. 11. Subject’s parent or LAR are willing to sign the ICF.
Exclusion criteria
Exclusion criteria: Subject’s meeting any of the following criteria are not eligible for the study: 1. Subject has been diagnosed with Lactose Intolerance & Galactosemia according to medical records or parent or LAR report. 2. Subject has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or parent or LAR report. 3. Subject has been diagnosed with a developmental disability, including pathological reason for stunted & wasting, physical disorders such as cerebral palsy, or developmental delay according to medical records or parent or LAR report. 4. Subject with recent history (within 3 months prior to signing ICF) of surgery, serious infections or injuries 5. Subject who is immunocompromised (e.g. HIV infection, AIDS, congenital immunodeficiency) or has known congenital diseases or malformations (e.g. gastrointestinal malformations) or has a history of endocrine abnormality or has chronic illnesses or conditions (e.g. jaundice, asthma, diabetes, cancer, tuberculosis, diarrhea, etc) or medications (e.g. systemic corticosteroids) which could interfere with the study objectives 6. 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 percent) in the past 3 months prior to screening 7. Subject on restrictions that prevent adherence to the diet plan, which is advised by the study center nutritionist during dietary advice 17 8. Subject with known food allergies as reported by parent or LAR 9. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in height-for-age WHO percentileTimepoint: at 6 months compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in height-for-age WHO percentile 2. Change in height-for-age WHO z-score 3. Change in weight-for-height WHO percentile 4. Change in weight-for-height WHO percentile 5. Change in weight-for-height WHO z-score 6. Change in WHO BMI for age z-score and percentile 7. Change in weight for age WHO z- score and percentile 8. Change in mid upper arm circumference-for-age WHO z-score and percentile 9. Number of sick days 10. Number of sick episodes 11. Change in calorie intake Timepoint: at 3 months compared to baseline. at 3 and 6 months compared to baseline. at 3 months compared to baseline. at 6 months compared to baseline. at 3 and 6 months compared to baseline. at 3 and 6 months compared to baseline at 3 and 6 months compared to baseline at 3 and 6 months compared to baseline at 3 and 6 months at 3 and 6 months at 3 and 6 months compared to baseline | — |
Countries
India
Contacts
Public ContactDr Aquil Faruqui
Jehangir Clinical Development Centre Pvt Ltd
Outcome results
None listed