se of nutritional supplement in growing undernourished children.

Phase 4

• Conditions: Health Condition 1: E441- Mild protein-calorie malnutrition

• Registration Number: CTRI/2021/12/038976
• Lead Sponsor: SUN PHARMACEUTICAL INDUSTRIES LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Clinically healthy children between 2-6 years of age and at risk of undernutrition defined as those between less than -1 and â??2 standard deviations of the WHO Child Growth Standards Median for weight for age.

2. Children who are picky eaters, defined as below, between 2-6 years of age and at risk of undernutrition.

3. Parents of children willing to give written informed consent

Picky eating was defined as having at least two of the following:

- eating only a limited number of foods;

- being unwilling to try new foods;

- refusing to eat vegetables and/or foods from other food groups;

- showing strong food likes and dislikes;

- displaying behaviour that disrupted mealtimes

Exclusion Criteria

1. Children less than 2 years and greater than 6 years of age will be excluded.

2. Children with moderate or severe malnutrition

3. Lactose intolerant children

4. Gluten intolerant children

5. Hypersensitivity to any ingredient in product

6. History of preterm delivery

7. Birth weight less than 2500 or greater than 4000 g

8. Ongoing or Recurrent infections, diarrhoea, known case of acute and chronic hepatitis B or C, HIV or tuberculosis, or diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases, or diagnosis of congenital or genetic disorder or infantile anorexia nervosa.

9. Children under medications or agents that could modulate body weight including but not limited to diuretics, appetite stimulants, steroids, and growth hormones

10. Children with of history of consumption of any other nutritional supplement within last 3 months of enrolment in study.

11. Children who had an obese parent defined as measured or self-reported BMI greater than equal to 28 kg/m2; to minimise the impact of genetic and family environmental influences on childhood overweight development.

Study & Design

• Study Type: Interventional
• Study Design: Not specified