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Effects of oral nutrition supplement on the nutritional status of infants aged 6–12 months

Effects of consuming oral nutrition supplement on the nutritional status of infants aged 6–12 months: a randomized parallel-group trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13402097
Enrollment
195
Registered
2026-04-27
Start date
2025-04-02
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional status of infants aged 6–12 months Nutritional, Metabolic, Endocrine

Interventions

This study uses a randomized, parallel-group controlled design involving infants aged 6 to 12 months with normal weight-for-age at baseline. A total of 195 participants are enrolled and randomly assig

Sponsors

Nestlé Philippines Inc.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 8 Months

Inclusion criteria

Inclusion criteria: 1. Infants aged 6 months to 8 months at baseline with normal weight for age defined as between minus 2 and plus 2 weight for age z scores according to the WHO Child Growth Standards 2. No known allergy to wheat, soya or cow’s milk 3. Not suffering from diarrhoea, respiratory infection or fever at baseline 4. Not currently participating in any complementary feeding programme 5. Not planning to move residence for the duration of the intervention 6. Written informed consent signed by a parent or legal guardian 7. Parents or caregivers willing to participate in nutrition education class activities 8. Infant parent or legal guardian is of the legal age of majority, able to understand the informed consent form and other relevant study documents, and willing and able to comply with the study protocol 9. Existing breastfeeding and or milk feeding practices will not be altered by the study. Feeding practices will be recorded and accounted for in the analysis as potential confounding variables. Infants with normal weight will be eligible regardless of feeding practices

Exclusion criteria

Exclusion criteria: 1. Undergoing treatment on any chronic ailment, diagnosed as suffering from any sort of illness e.g. fever, diarrhea, stomach ache, cough and colds at baseline 2. Participant in an on-going complementary feeding program 3. With allergy on wheat, soya, cow’s milk 4. With physical disability that affects normal feeding of infants e.g. cleft lip or palate 5. Parents/caregivers who are not willing to participate in the feeding and NE class activities 6. Without signed parental ICF 7. Overweight, obese, undernourished 8. Low-birth-weight (LBW) or premature baby 9. Children identified with moderate acute malnutrition (MAM) or severe acute malnutrition (SAM) will be referred to the nearest health facility for appropriate management

Countries

Philippines

Contacts

Public ContactImelda;Jezreel Agdeppa;Ann Zamora

;

iangelesagdeppa@yahoo.com.ph;zjezreelann@gmail.com; j.zamora@gipdex.com+63 9175460189;+63 9674606618

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026