Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits

September 18, 2009 updated by: Annamalai University

Efficacy of Consumption of Micronutrient Fortified Yoghurt on Biochemical Markers, Cognitive Development, Morbidity and Physical Growth Among 6-9 Years School Going Children in Bangladesh - A Double Masked, Randomized Trial With a Concurrent Matched Control

To evaluate the efficacy of consumption of yoghurt fortified with 30% recommended dietary allowance (RDA) of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year in comparison to same yoghurt without fortification for change in mean levels and proportion deficient for markers of status of Iron (Hemoglobin, Serum ferritin, Serum transferrin, ZnPP), Vitamin A (Plasma retinol levels), Iodine (Urinary iodine levels), Zinc (Plasma zinc), and copper (Plasma copper levels, sub sample of children); improvement in cognitive development, reduction in episodes/days of illnesses (diarrhea, pneumonia, febrile illness), hospitalizations and morbidity causing absenteeism from school and improvement in growth. Additionally to evaluate the efficacy of consumption of fortified and non fortified yoghurt (plain yoghurt) for a period of 12 months in comparison to pure control that do not receive any intervention in the improvement in cognitive development and physical growth. The main objective is to evaluate the impact of addition of micronutrients to Yoghurt and can be best addressed by RCT. The effect of taking yoghurt per se cannot be blinded so for that the investigators have included a concurrent control.

Hypothesis: Consumption of fortified yoghurt with 30% RDA of essential micronutrients (iron, zinc, vitamin A and iodine) for a period of one year will improve the micronutrient status indicators, cognitive development, and growth and reduce morbidity of children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study population: Children aged 6-9 years both boys and girls from 6 primary schools of Gabtali town of Bogra district in Bangladesh.

Sample Size: 1200 children (400 in each group) Enrollment of eligible children and Base line information: Details of all eligible children will be obtained from the schools to be a part of the study and their parents will be contacted for an appointment either by telephone or sending a note. Consent for participation will be sought after evaluating inclusion and exclusion criteria and will be randomized to receive either fortified or non fortified yoghurt, similarly consent will be obtained from the parents of children from the non yoghurt area who will not be given any intervention. Baseline information on socioeconomic information, retrospective morbidity information of the child for the last 15 days, hospitalization, hygiene and sanitation information will be recorded. Baseline clinical assessments and anthropometric measurements will be conducted. 5 ml of venous blood sample (approx. one spoonful of blood) and mid stream urine sample will be obtained by a trained nurse/technician employed by the project. Developmental assessments measuring children's intelligence and executive functioning (WISC, KCPT, WCST) will be conducted using standardized tests. Blood/urine sampling will not be done for the children in the pure control group (no intervention).

Randomization and blinding: Randomization schedule will be drawn using randomization by permuted blocks of fixed length which is appropriate for double blind studies.

Intervention and Follow-up: For the yoghurt group, the intervention would be supplied in a disposable 80 g cup. Computer labels will be generated on a daily basis with identification information and the allocated code printed on it for all the enrolled children in the database and the appropriate yoghurt cups will be labeled for each child. The labeled yoghurt cups will be then handed over to the school supervisor to deliver to the student in his/her supervision during lunch break of the school. Children will receive the intervention for a period of 12 months. Children from the matched control in the non-yoghurt area will not receive any intervention.

Mid Study data collection: Similar to the baseline, anthropometric measurements will be done and again a 5ml blood sample (approx one spoonful of blood) will be obtained to assess the difference in the markers at baseline and mid study. Blood/urine sampling will not be done for children in the pure control.

End Study data collection: An end study similar to the baseline, anthropometric measurements will be taken and again a 5ml blood sample (approx one spoonful of blood) will be obtained to assess the difference in the markers at baseline and end study. Blood/urine sampling will not be done for the children in the pure control (no intervention group). Detailed developmental assessments using a battery of computerized neuropsychological (CANTAB) and cognition tests (WISC, K-CPT and WCST) will be conducted. Academic achievement will be assessed using school report cards.

Intervention Groups: There will be one study group with one control group. Both the groups would receive yoghurt in a 80 g cup. The study group would receive yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1325

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Bangladesh
      • Bogra, Bangladesh
        • Recruiting
        • Department of Community Medicine, SZMC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahsan Habib, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children aged between 6 to 9 yrs of age,
  • enrolled in the school,
  • not severely malnourished requiring rehabilitation and micronutrient supplement, AND
  • consent to participate.

Inclusion is only based on age and locale: 6-9 years in Gabtali schools and both genders will be enrolled.

Exclusion Criteria:

  • children who are severely malnourished and requiring hospitalization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Fortified Yoghurt
Yoghurt with fortification of Micronutrients, yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine. The salts used for fortification will be iron- Ferric pyrophosphate micronized, zinc - zinc gluconate, Iodine - Potassium Iodide, Vitamin A - Vitamin A acetate.
Dietary supplement: Fortified Yoghurt
The study group would receive yoghurt fortified with 1/3rd RDA of iron, zinc, vitamin A and iodine. The salts used for fortification will be iron- Ferric pyrophosphate micronized, zinc - zinc gluconate, Iodine - Potassium Iodide, Vitamin A - Vitamin A acetate.
Placebo Comparator: Yoghurt
Plain Yoghurt same as in fortified arm but without fortification
Dietary supplement: Yoghurt
Plain yoghurt same as in intervention group without fortification
No Intervention: Control
Non blinded group given no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Morbidity
Time Frame: 0 months, 6 months, 12 months
0 months, 6 months, 12 months
Growth
Time Frame: 0 months, 6 months, 12 months
0 months, 6 months, 12 months
Development
Time Frame: 0 months, 6 months, 12 months
0 months, 6 months, 12 months
School performance
Time Frame: 0 months, 6 months, 12 months
0 months, 6 months, 12 months
Status Indicators for iron, zinc, vitamin A and iodine
Time Frame: 0 months, 6 months, 12 months
0 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Annamalai University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins Bloomberg School of Public Health
Global Alliance for Improved Nutrition
Department of Community Medicine SZMC, Bogra Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Global Alliance G#102512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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