The effect of a ;locally formulated nutritional supplement on nutritional status and surgical outcome, in children with cleft lip and palate: A randomised controlled clinical study.

The effect of a locally formulated nutritional supplement on nutritional status and surgical outcome, in children with cleft lip and palate: A randomised controlled clinical study.

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR202408800103976

Enrollment

Registered

2024-08-29

Start date

2024-06-21

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Paediatrics

Interventions

Nutribom maize

Locally formulated nutritional supplement

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All participants with nonsyndromic cleft lip and palate 2. Participants aged 6 months to 13 months 4. Participants with cleft lip and palate whose parents consent to be part of this study 5. Participants with unilateral cleft palate

Exclusion criteria

Exclusion criteria: 1. Participants with cardiac and other congenital malformations that may prevent them from thriving 2. Participants who are chronically ill from background medical conditions 3. Participants with syndromic cleft lip and palate 4. Patients with orofacial clefts – Tessier cleft 5. Participants with bilateral cleft palate 6. Participants whose parents/guardians do not give consent for the study. 7. Participants with coagulopathies and other medical conditions which may affect surgery and healing post operatively. 8. Participants with cleft width > or equal to 15mm133

Design outcomes

Primary

Measure	Time frame
1. Degree of changes in the clinical parameters (anthropometric measurements) which include weight, height, MUAC from baseline to the 6th month 2. Degree of changes in laboratory parameters (total protein, serum albumin and serum globulin) from baseline to the 6th month.	—

Secondary

Measure	Time frame
1. Surgical site infection is defined as infections 2. Wound dehiscence 3. Palatal fistula	—

Countries

Nigeria

Contacts

Public ContactFatima Kyari

Senior Resident in Oral and Maxillofacial Surgery

haneefahluv2012@gmail.com+2348035618530

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026