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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Pakistan1 site
  • Bilal Colony Centre

    Karachi, Sindh, 74800

Other trials in Pakistan

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 groups in NCT01412411
Study groupRoleWhat they receive
Nutrition Education plus Multiple Micronutrient FortificationActive comparatorIn 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 EductaionActive comparatorIn this group, along with the nutritional education, Oral Iron Supplementation was given.
Receives: Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion
Nutrition Education GroupActive comparatorThis 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.

  1. 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)
  1. Compliance to intake of study medicines

    Compliance was checked to ensure that subjects are taking study medicines properly.

    Measured: 12 months

  2. Morbidity Assessment

    Subjects were assessed on fortnighty basis to see any change in the morbidity.

    Measured: 12 months

  3. 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.

  1. First posted9 Aug 2011 (estimated)
  2. Study startOct 2005
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

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)
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

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.

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