Evaluation of the Effect of Pure Canterbury Stage 1 Infant Formula Milk Powder on the Growth of Infant 0-6 Months of Age

NCT02239588 | Completed Phase 4 DMC

• 1 other identifier: 13-SC-7-BRD-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This was a randomized, double-blind, single-center, placebo-controlled, three-arm study, with a 12-week intervention period. The objectives of this study were to evaluate the effect of Pure Canterbury Stage 1 (0-6 months) milk powder on:

1. 1.Bone health;
2. 2.Infants growth;
3. 3.Intestinal health;
4. 4.Gastrointestinal tolerance to the test product;

Conditions

Growth Acceleration

Outcome Measures

Primary Outcomes (1)

• Bone density change from baseline (Tibial speed of sound measurement)

  Week 12 values minus Baseline (week 0) values

  After 12 weeks of study intervention

Secondary Outcomes (7)

• Growth measurements

  Baseline (week 0), week 4, week 8, week 12

• Stool consistency

  Daily up to 12 weeks

• Fecal short-chain fatty acid concentration

  Baseline (week 0), week 12

• Fecal bacteria count

  Baseline (week 0), week 12

• Intestinal adherence questionnaire

  Daily up to 12 weeks

Study Arms (3)

Pure Canterbury milk powder

EXPERIMENTAL

Oral consumption of infant formula (0-6 months) milk powder

Other: Oral consumption

Other infant formula milk powder

ACTIVE COMPARATOR

Oral consumption of milk powder (other than the experimental product) selected by subjects' parents. The products including: 1. Yashili Ambery Infant Formula Milk Powder (Stage 1: 0-6 months) 2. Yashili Newwit Infant Formula Milk Powder (Stage 1 0-6 months) 3. Yashili α-golden stage Infant Formula Milk Powder (Stage 1 0-6 months) 4. Abbott Similac Infant Formula Milk Powder (Stage 1 0-6 months) 5. Wyeth S-26 SMA Gold Infant Formula Milk Powder (Stage 1 0-6 months) 6. Beingmate Love plus Infant Formula Milk Powder (Stage 1 0-6 months)

Other: Oral consumption

Breast milk

PLACEBO COMPARATOR

Oral consumption of breast milk

Other: Oral consumption

Interventions

Oral consumption OTHER

Daily oral consumption for 12 weeks: Placebo; Pure Canterbury; Other infant formula milk powder: 1. Yashili Ambery Infant Formula Milk Powder (Stage 1 0-6 months) 2. Yashili Newwit Infant Formula Milk Powder (Stage 1 0-6 months) 3. Yashili α-golden stage Infant Formula Milk Powder (Stage 1 0-6 months) 4. Abbott Similac Infant Formula Milk Powder (Stage 1 0-6 months) 5. Wyeth S-26 SMA Gold Infant Formula Milk Powder (Stage 1 0-6 months) 6. Beingmate Love plus Infant Formula Milk Powder (Stage 1 0-6 months)

Breast milk; Other infant formula milk powder; Pure Canterbury milk powder

Eligibility Criteria

• Age: 7 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants 7\~90 days old;
• Fed by breast milk before enrollment;
• Concent form signed by parents

You may not qualify if:

• Twins, multiple births, low birth weight children, over birth weight children or early birth children with gestational age less than 37 weeks;
• During pregnancy, the mothers had pregnancy complications or other disease that may affect the study results;
• Having serious diseases that may affect study interventions, such as neonatal sepsis, pneumonia (associated with respiratory failure), heart failure and other diseases;
• Having neonatal diarrhea or acute respiratory infections within 48 hours before enrollment;
• Having potential metabolic diseases, chronic diseases, congenital malformations, central nervous system disorders, neuromuscular disorders or diseases affecting bone metabolism that may affect growth or the study results;
• Having taken any food containing prebiotics or probiotics within 15 days of enrollment;
• Having gluten allergy (celiac disease);
• Body weight-to-height Z-value \<-3 according to the standard of WHO;
• Receiving hormone therapy and intravenous nutrition;
• Lactose intolerance;
• Have participated in other clinical studies within 3 months prior to the date of screening;
• Unable to comply the study schedule

Sponsors & Collaborators

• Bright Dairy & Food Co., Ltd: lead

Study Sites (1)

XinHua Hospital Affiliated to Shanghai JiaoTong University

Shanghai, China

Location

MeSH Terms

Interventions

Economics

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Study Officials

• Xiaoyang Sheng, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 15, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 15, 2014

Record last verified: 2014-09

Locations

CN (1)