A clinical study the effects of Nutritional supplement in children aged 4 to 6 years
- Registration Number
- CTRI/2018/12/016576
- Lead Sponsor
- utricia International Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 216
The inclusion criteria for the study are as follows:
1. Subject (boy or girl), 4-6 years of age, and residing in India;
2. For subject 4-5 years of age, WHO MGRS 2006 weight-for-age z-scores between -1 and -2 and for subjects 5-6 years of age, IAP 2015 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 3 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 are willing to accommodate daily home visits by the study personnel for provision of study product;
Subjectâ??s parent/LAR willing to sign the informed consent form (ICF)
1. Subject with recent history (within 3 months prior to signing ICF) of surgery, serious infections, or injuries.
2. Subject who is malnourished, immunocompromised.
3. Subject with known or suspected intolerance or hypersensitivity to the study product (or closely related compounds) or any of their stated ingredients.
4. Subject with lactose intolerance and/or aversion to drinking milk
5. 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 taking a nutritional supplement (with average consumption of >=10%) in the past 3 months prior to screening
6. Subject on restrictions that prevent adherence to the diet plan, which is advised by the study center nutritionist during dietary advice
7. Subject with known food allergies as reported by parent/LAR
8. Subject currently participating, or has participated in a drug/device study or a nutritional program run by the local government or NGO within a period of 30 days prior to screening
9. 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
10. Subject related to an employee of the sponsor or the study site staff
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method