Evaluation of the Effect of Pure Canterbury Stage 1 Infant Formula Milk Powder on the Growth of Infant 0-6 Months of Age
Condition: Growth Acceleration
Study type: Interventional
Phase: Phase 4

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. Bone health;

        2. Infants growth;

        3. Intestinal health;

        4. Gastrointestinal tolerance to the test product;

      g) Incidence of Eczema
    

Detailed description: 
      • Quality control of the study: 1.1 Study monitoring and source data verification: Monitoring
      was done according to the monitoring plan by a representative of the investigator, who
      checked the case report forms for completeness and clarity, and cross-checked them with
      source documents. In addition to the monitoring visits, frequent communications (letter,
      telephone, fax, e-mail), by the study monitor ensured that the investigation was conducted
      according to protocol design and regulatory requirements. Study close-out was performed by
      the study monitor upon closure of the study.

      1.2 On-site audits: Domestic and foreign regulatory authorities, the IEC/IRB, and an auditor
      authorized by the sponsor may request access to all source documents, case report forms, and
      other study documentation for on-site audit or inspection. Direct access to these documents
      was guaranteed by the investigator, who must provide support at all times for these
      activities. Medical records and other study documents may be copied during audit or
      inspection provided that subject names are obliterated on the copies to ensure
      confidentiality.

      1.3 Documentation: A case report form was provided for each subject. All protocol-required
      information collected during the study was entered by the investigator, or designated
      representative, in the case report form. Details of case report form completion and
      correction were explained to the investigator.

      The investigator, or designated representative, should complete the case report form pages as
      soon as possible after information is collected, preferably on the same day that a study
      patient is seen for an examination, treatment, or any other study procedure. Any outstanding
      entries must be completed immediately after the final examination. An explanation should be
      given for all missing data.

      A source data location list was prepared prior to study initiation. This list was filed in
      both the trial master file and the investigator study file and updated as necessary.

      The completed case report forms were reviewed and signed by the investigator named in the
      clinical study protocol or by a designated sub investigator.

      The sponsor would retain the original of all completed case report forms. The principal
      investigator kept the copies of all completed case report forms for 25 years after the trial
      based on Good Clinical Practice (GCP) requirements.

      • Quality assurance of study products: All products used in this study were manufactured and
      provided by Bright Dairy & Food Co., Ltd. The quality test of study products was conducted by
      Shanghai dairy products quality supervision and inspection station. The study products were
      stored at the study site and assigned to the subjects by the investigator. The amount of
      products received and assigned were filed on product distribution list by the investigator.
      The study products were not allowed to be given to anyone who didn't participated in the
      study. No sales of unassigned products was allowed. After the completion of the study, the
      unassigned products need to be returned to Bright Dairy & Food Co., Ltd.

      The products were labeled with study code. A master participation list was completed which
      identifies each patient full name and unique identification number. The identity of the
      specific product was blind to patients, support staff and investigators. The unmasking
      occurred to the investigators and statistical analyses team only after completion of
      statistical analyses.

      • Data management: Study data were recorded on Case Report Forms (CRFs) and then entered into
      saved in the form of Excel files. Data was double entered and cross-validated.

      • Management of subject withdrawal: A number of 120 subjects were enrolled in the study.

      Subjects may be withdrawn from the study for the following reasons:

        -  At their own request or at the request of their legally authorized representative,

        -  If, in the investigator's opinion, continuation in the study would be detrimental to the
           patient's well-being,

        -  If they are lost to follow-up. In all cases, the reason for and date of withdrawal must
           be recorded in the Exit Form and in the subject's medical records and the sponsor's
           representative must be notified within 5 days. The subject must be followed up to
           establish whether the reason was an adverse event, and, if so, this must be reported in
           accordance with the procedure of an adverse event (described bellow). The investigator
           must make every effort to contact subject lost to follow-up. Attempts to contact such
           subject must be documented in the subject's records (e.g., dates and times of attempted
           telephone contact).

      Investigator must be notified of all serious or unexpected adverse events within 48 hours.
      Notification does not depend on whether there is a connection to the study formula or not.
      All adverse events must be documented on the appropriate pages of the case report forms.

      • Statistical analysis plan: Analysis was performed for the intent-to-treat population.
      Chi-square test was used comparison among study groups for categorical data. For continuous
      outcomes, one-way ANOVA was used for between-group comparison, followed by multiple
      comparison with Bonferroni adjustment. Paired t-test was used for pre-post comparison within
      each study group. Non-parametric methods were used for non-normal data, data with unequal
      variances. The analysis was completed using the statistical package SPSS17.0.
    

Intervention name(s): Oral consumption
Intervention type(s): Other
Intervention description(s): Daily oral consumption for 12 weeks:
Placebo;
Pure Canterbury;
Other infant formula milk powder:
Yashili Ambery Infant Formula Milk Powder (Stage 1 0-6 months)
Yashili Newwit Infant Formula Milk Powder (Stage 1 0-6 months)
Yashili α-golden stage Infant Formula Milk Powder (Stage 1 0-6 months)
Abbott Similac Infant Formula Milk Powder (Stage 1 0-6 months)
Wyeth S-26 SMA Gold Infant Formula Milk Powder (Stage 1 0-6 months)
Beingmate Love plus Infant Formula Milk Powder (Stage 1 0-6 months)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care