Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil

NCT01431469 | Completed

• 1 other identifier: 6001
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.

Conditions

Acute Respiratory Infection; Diarrheal Disease

Outcome Measures

Primary Outcomes (1)

• Episodes of acute respiratory infections and diarrheal disease

  28 weeks

Secondary Outcomes (10)

• Occurrence of allergic manifestations

  28 weeks

• Systemic antibiotic use

  28 weeks

• Duration of acute respiratory infection and diarrheal disease

  28 weeks

• Changes in stool patterns

  28 weeks

• Fecal and serum immune markers

  28 weeks

Study Arms (2)

Cow's Milk

PLACEBO COMPARATOR

Powdered Whole Cow's Milk

Dietary Supplement: Cow's milk

Follow-On Formula

EXPERIMENTAL

Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide

Dietary Supplement: Follow-On Formula

Interventions

Cow's milk DIETARY_SUPPLEMENT

Powdered Whole Cow's Milk

Cow's Milk

Follow-On Formula DIETARY_SUPPLEMENT

Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide

Follow-On Formula

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child 12-48 months of age
• Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
• Signed informed consent

You may not qualify if:

• Child who is receiving predominantly breast-milk
• Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
• Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
• Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
• Child's z-score of weight for length/height \< -3 according to World Health Organization criteria

Sponsors & Collaborators

• Mead Johnson Nutrition: lead
• Federal University of Bahia: collaborator

Study Sites (1)

Universidade Federal da Bahia, Hospital Universitário Prof. Edgard Santos Complexo HUPES, Centro Pediátrico Professor Hossanah Oliveira, Centro da Pesquisas Fima Lifshitz, Rua Augusto Viana s/n Canela

Salvador, Estado de Bahia, CEP 401 10-060, Brazil

Location

Related Publications (1)

• Pontes MV, Ribeiro TC, Ribeiro H, de Mattos AP, Almeida IR, Leal VM, Cabral GN, Stolz S, Zhuang W, Scalabrin DM. Cow's milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCT. Nutr J. 2016 Feb 27;15:19. doi: 10.1186/s12937-016-0138-0.

  PMID: 26920136 DERIVED

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 9, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

BR (1)