AnemiaCFSNCT01412411
Appropriate Complmentary Feeding Strategies in Infants
A study testing Nutritionl Education, Oral Iron Supplementation along with Nturition Eductaion and Multiple micronutrient fortification plus Nutrition Education in people with Anemia, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The purpose of this study has been to understand the prevalence of under nutrition and develop effective interventions for improving growth and micronutrient status of infants receiving complementary foods. Read more about this study
- Who is it for?
- Ages 6 to 8 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Nutritionl Education, Oral Iron Supplementation along with Nturition Eductaion and Multiple micronutrient fortification plus Nutrition Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2005to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children between the age of 6 months to 8 months.
Who cannot join
- Children who are sick to an extent that cannot take anythign oral were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Appropriate Complementary Feeding Strategies in Infants: An Evaluation of Various Strategies to Assess the Growth and Health of the Infants.
The purpose of this study has been to understand the prevalence of under nutrition and develop effective interventions for improving growth and micronutrient status of infants receiving complementary foods.
In this community based randomized clinical trial, the nutrition education package implemented aimed to improve hematological parameters including the micronutrient status and to see effect on growth indicators.
Read the detailed description
Transition from exclusive breast feeding to complementary feeding poses many challenges as the demand for nutrients necessary for optimum growth and development increases steadily. Malnutrition and micronutrient malnutrition can be inter-generational and affect pregnant mothers and consequently the baby may be born with deficient micronutrient stores, especially those of iron. This deficiency can be further exacerbated by sub-optimal practices of breast feeding. Globally, iron deficiency is the most common cause of anemia estimated to affect nearly 2 billion people especially preschool children. In Pakistan, 56 % of children under the age of five years are estimated to have iron deficiency anemia and 13 % are also severely malnourished. These deficiencies affect not only physical growth but also mental development with significant impact on immunity and increased burden of infections. It is uncertain what the most appropriate intervention strategy is and a wide range of options are mentioned including dietary diversification through nutrition education, provision of fortified foods, iron supplementation and home-based fortification of complementary foods with micronutrient powders such as Sprinkles.
In an effort to understand the prevalence of under nutrition and develop effective interventions for improving growth and micronutrient status of infants receiving complementary foods, I undertook a prospective community-based randomized controlled efficacy trial in a representative urban population of Karachi. Infants and mothers were identified after birth and enrolled in the study to receive one of the interventions through community health workers at the age of six months. The enrolled infants were placed in three groups - defined as Nutr Education (Nutr Edu), Oral iron supplementation (OIS) and Multiple micronutrient fortification (MMF). Nutrition education component was common to all the groups. Through nutritional education sessions held in the community, dietary diversification along with continuation of breast feeding was stressed to enhance the intake of diet, rich in iron, and other micronutrients. A cohort of 451 infants (177 in group Nutr Edu, 141 in group OIS and 133 in MMF) were followed for three months (till the end of treatments) for growth, micronutrient status, and morbidity rate and thereafter followed for another three months to evaluate anthropometric parameters.
- Conditions
- Anemia
- Being tested
- Nutritionl Education, Oral Iron Supplementation along with Nturition Eductaion, Multiple micronutrient fortification plus Nutrition Education
- Keywords
- Anemia, Growth, Infants, Focus of the study is to assess the level of anemia and growth indicators among the infants
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritionl EducationBehavioural
to assess the change in behaviour
Oral Iron Supplementation along with Nturition EductaionDietary supplement
Multiple micronutrient fortification plus Nutrition EducationDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education plus Multiple Micronutrient Fortification | Active comparator | In this group along with the nutritional education, multiple micronutrient fortification was given in the form of Sprinkles Receives: Dietary Supplement: Multiple micronutrient fortification plus Nutrition Education |
| OIS plus Nutritional Eductaion | Active comparator | In this group, along with the nutritional education, Oral Iron Supplementation was given. Receives: Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion |
| Nutrition Education Group | Active comparator | This is group was followed for the growth of the child and was given Nutritional Education to children's mothers. Receives: Behavioral: Nutritionl Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
To assess the impact of supplementation and multiple micronutrient fortification in comparison to nutritional education strategy to assess the biochecmical and growth indicators
Measured: 12 months
Secondary outcomes (3)
Compliance to intake of study medicines
Compliance was checked to ensure that subjects are taking study medicines properly.
Measured: 12 months
Morbidity Assessment
Subjects were assessed on fortnighty basis to see any change in the morbidity.
Measured: 12 months
Developmental Assessment
Subjects were assessed on monthly developmental milestones among the three groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startOct 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, European Union
- Investigators
- Aziz AJ Abdul Rehman Jiwani, MBBS, PhD, Principal investigator, Aga Khan UniversityZulfiqar ZB Bhuta, MBBS, MCPS (Peds), FCPS (Peds), Study chair, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412411
- Sponsor's protocol ID
- 480/Peds-ERC-05
- Acronym
- CFS
- Status last verified
- Mar 2008
- First submitted
- 3 Aug 2011
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Complementary Feeding Strategies in Infants: An Evaluation of Various Strategies to Assess the Growth and Health of the Infants.
- ClinicalTrials.gov ID
- NCT01412411
- Acronym / sponsor ID
- CFS / 480/Peds-ERC-05
- Conditions
- Anemia
- Keywords
- Anemia, Growth, Infants, Focus of the study is to assess the level of anemia and growth indicators among the infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, European Union
- Study start
- Oct 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 9 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study has been to understand the prevalence of under nutrition and develop effective interventions for improving growth and micronutrient status of infants receiving complementary foods.
In this community based randomized clinical trial, the nutrition education package implemented aimed to improve hematological parameters including the micronutrient status and to see effect on growth indicators.
Detailed description
Transition from exclusive breast feeding to complementary feeding poses many challenges as the demand for nutrients necessary for optimum growth and development increases steadily. Malnutrition and micronutrient malnutrition can be inter-generational and affect pregnant mothers and consequently the baby may be born with deficient micronutrient stores, especially those of iron. This deficiency can be further exacerbated by sub-optimal practices of breast feeding. Globally, iron deficiency is the most common cause of anemia estimated to affect nearly 2 billion people especially preschool children. In Pakistan, 56 % of children under the age of five years are estimated to have iron deficiency anemia and 13 % are also severely malnourished. These deficiencies affect not only physical growth but also mental development with significant impact on immunity and increased burden of infections. It is uncertain what the most appropriate intervention strategy is and a wide range of options are mentioned including dietary diversification through nutrition education, provision of fortified foods, iron supplementation and home-based fortification of complementary foods with micronutrient powders such as Sprinkles.
In an effort to understand the prevalence of under nutrition and develop effective interventions for improving growth and micronutrient status of infants receiving complementary foods, I undertook a prospective community-based randomized controlled efficacy trial in a representative urban population of Karachi. Infants and mothers were identified after birth and enrolled in the study to receive one of the interventions through community health workers at the age of six months. The enrolled infants were placed in three groups - defined as Nutr Education (Nutr Edu), Oral iron supplementation (OIS) and Multiple micronutrient fortification (MMF). Nutrition education component was common to all the groups. Through nutritional education sessions held in the community, dietary diversification along with continuation of breast feeding was stressed to enhance the intake of diet, rich in iron, and other micronutrients. A cohort of 451 infants (177 in group Nutr Edu, 141 in group OIS and 133 in MMF) were followed for three months (till the end of treatments) for growth, micronutrient status, and morbidity rate and thereafter followed for another three months to evaluate anthropometric parameters.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education plus Multiple Micronutrient Fortification | Active comparator | Dietary Supplement: Multiple micronutrient fortification plus Nutrition EducationIn this group along with the nutritional education, multiple micronutrient fortification was given in the form of Sprinkles |
| OIS plus Nutritional Eductaion | Active comparator | Dietary Supplement: Oral Iron Supplementation along with Nturition EductaionIn this group, along with the nutritional education, Oral Iron Supplementation was given. |
| Nutrition Education Group | Active comparator | Behavioral: Nutritionl EducationThis is group was followed for the growth of the child and was given Nutritional Education to children's mothers. |
Who may qualify
- Ages
- 6 to 8 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children between the age of 6 months to 8 months.
Key exclusion criteria (1 listed)
- Children who are sick to an extent that cannot take anythign oral were excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritionl Educationto assess the change in behaviour | Behavioural | Nutrition Education Group |
| Oral Iron Supplementation along with Nturition Eductaion | Dietary supplement | OIS plus Nutritional Eductaion |
| Multiple micronutrient fortification plus Nutrition Education | Dietary supplement | Nutrition Education plus Multiple Micronutrient Fortification |
Primary outcome
Anemia
Time frame: 12 months
To assess the impact of supplementation and multiple micronutrient fortification in comparison to nutritional education strategy to assess the biochecmical and growth indicators
3 secondary outcomes
Compliance to intake of study medicines
Time frame: 12 months
Morbidity Assessment
Time frame: 12 months
Developmental Assessment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aziz AJ Abdul Rehman Jiwani, MBBS, PhD principal investigator
Aga Khan University
Zulfiqar ZB Bhuta, MBBS, MCPS (Peds), FCPS (Peds) study chair
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritionl Education, Oral Iron Supplementation along with Nturition Eductaion and Multiple micronutrient fortification plus Nutrition Education in people with Anemia, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011; AzTrials last refreshed its copy on 6 Nov 2026.