Micronutrient DeficienciesNCT03450174
Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children
A study testing Formative messgaes, Fortified product and Fortified product plus in people with Micronutrient Deficiencies and Anemia, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
Trial summary
Multiple micro-nutrient deficiencies in Pakistan is wide spread, there is dire need to address these by using smart solutions, among them multiple fortified product (fudge) is an alternate possible way to address this issue. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Micronutrient Deficiencies, Anemia, Fortification
- What is being tested?
- Formative messgaes, Fortified product and Fortified product plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Oct 2017to 30 Aug 2018
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3-5 years of age
- no medical complication
- from middle-income group within the semi-urban population
Who cannot join
- illness/ infections (TB, Malarial drug)
- non-attendant
- severe anemia/micro nutrient deficiency
- thyroid disease
- medication/supplementation
- not willing to participate
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Veterinary and Animal Sciences
Lahore, Punjab Province, 54000
About this study
Official title: Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children: A Randomize Control Trial
Multiple micro-nutrient deficiencies in Pakistan is wide spread, there is dire need to address these by using smart solutions, among them multiple fortified product (fudge) is an alternate possible way to address this issue. Fortified products have the potential to reduce micronutrient deficiencies in children, therefore in current study children from 3-5 years will receive fortified product along with enhance nutrition promotional information to bring change in their dietary practices and nutritional indices.
Read the detailed description
As per the National Nutrition Survey, 2011 anaemia (iron deficiency) affected the children severely as one in three children under the age of 5 anemic, whereas prevalence of vitamin A deficiency among children under 5 years is more than 50%, similarly Zinc deficiency children and vitamin D deficiency prevalence in children is more than 40%.
The numerous indicators of nutrition deficiencies are related to inadequately nutritious and safe food, illiteracy, malpractices along with lack of nutritional knowledge and other social and behavioral issues. A healthy and supportive nutritional status, direct toward better intellect and earning of individual, which boost the social impact and macro level change.
Childhood stunting and deficiencies in iron and iodine hamper cognitive development, school achievement and adult productivity by 2.5-19.8 percent subsequently adult anemia reduces work performance in manual labor in the agriculture area and overall resultant US$ 7.6 billion annually loss for Pakistan, which corresponds to nearly 3 percent of GDP all due to poor nutritional indicators, which are preventable. Therefore, in developing countries like Pakistan, robust need is required, to do evidence base and translational research which could be easily converted into action that improves nutritional status.
Food fortification with micro-nutrients is effective, cost-efficient and medium-term approach to improve micro-nutrient status of vulnerable groups and is sustainable once established to prevent these at cheaper cost. There is need to investigate the positive effects of multiple micronutrient administration on child development along with there is dire need for more research to investigate it comprehensively at community level.
Fortified food products such as (milk, wheat, rice, oil, and other) are already in existing strategies worldwide to prevent micro-nutrient deficiencies in society which is well established and currently there are several extensive activities are implemented to prevent these hidden hunger but required results are not achieved.
On the other hand, other smart solutions are emerging to prevent these deficiencies at wider level in best possible means, among them fortified candy with multiple micronutrients is one vehicle. Confectionery products have the potential to carry the micronutrient for better delivery and doesn't significantly affect the flavour, taste and texture of the product.
The objective of the study is to determine the nutritional status, factor causing micronutrient deficiencies in pre-school children in semi-urban area of Karachi and how fortified product and enhance nutritional knowledge can bring change in nutritional indicators and understanding of nutrition in community.
- Conditions
- Micronutrient Deficiencies, Anemia, Fortification, Undernutrition, Early Childhood Development
- Being tested
- Placebo, Formative messgaes, Fortified product, Fortified product plus
- Medical subject headings
- Anemia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
In control group, participants will receive only a placebo product
Formative messgaesBehavioural
In this group, participants will only receive daily formative messages
Fortified productDietary supplement
In this group, participants will receive fortified product on alternate day up till 8 months
Fortified product plusCombination product
In this group participants will receive fortified product on alternate day and formative messages up till 8 months
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | this group, only placebo product will be given Receives: Dietary Supplement: Placebo |
| Formative messages | Experimental | this group will be received only daily formative messages on diet diversity, healthy and best nutrition practices Receives: Behavioral: Formative messgaes |
| Fortified product | Experimental | this group will be received only fortified product on alternate day up to 6 months Receives: Dietary Supplement: Fortified product |
| Fortified product plus | Experimental | this group will receive fortified product along with daily messages on diet diversity and healthy nutrition practices Receives: Combination Product: Fortified product plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
To access the improvement in child Iron deficiency anemia
change in serum Hemoglobin, serum ferritin and serum transferrin receptors
Measured: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
To access the improvement in children Vitamin A status
Change in Serum retinol binding protein
Measured: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
To access the improvement in children Zinc status
Change in serum zinc
Measured: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
Secondary outcomes (3)
Difference in the children anthropocentric status
Mean z-scores (weight-for-age, length-for-age z-scores, weight-for-length) based on the WHO child growth standards 2006
Measured: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Effect on the household food security
Diet diversity score based on dietary intake and preferences by 24 hrs dietary recall and Household Food Security Scale
Measured: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Enhancement in the early childhood development indicators
Gain change in the cognitive, motor and socio-emotional assessment through questionnaire filled by caretaker
Measured: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start2 Oct 2017
- Primary completion28 Jul 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Micronutrient DeficienciesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Sindh Lady Health Worker Program for Family Planning and Primary Health Care, PCSIR Laboratories Complex Karachi Pakistan
- Responsible party
- Principal investigator, Fakhar Gulzar, University of Veterinary and Animal Sciences, Lahore - Pakistan
- Investigators
- Fakhar Gulzar, Principal investigator, University of Veterinary and Animal Sciences, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450174
- Sponsor's protocol ID
- UniversityVAS
- Status last verified
- Feb 2018
- First submitted
- 25 Jan 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children: A Randomize Control Trial
- ClinicalTrials.gov ID
- NCT03450174
- Acronym / sponsor ID
- UniversityVAS
- Conditions
- Micronutrient Deficiencies, Anemia, Fortification, Undernutrition, Early Childhood Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - PakistanUniversity, hospital or other
- Collaborators
- Sindh Lady Health Worker Program for Family Planning and Primary Health Care, PCSIR Laboratories Complex Karachi Pakistan
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 28 Jul 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 1 Mar 2018 (actual)
- 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.
Multiple micro-nutrient deficiencies in Pakistan is wide spread, there is dire need to address these by using smart solutions, among them multiple fortified product (fudge) is an alternate possible way to address this issue. Fortified products have the potential to reduce micronutrient deficiencies in children, therefore in current study children from 3-5 years will receive fortified product along with enhance nutrition promotional information to bring change in their dietary practices and nutritional indices.
Detailed description
As per the National Nutrition Survey, 2011 anaemia (iron deficiency) affected the children severely as one in three children under the age of 5 anemic, whereas prevalence of vitamin A deficiency among children under 5 years is more than 50%, similarly Zinc deficiency children and vitamin D deficiency prevalence in children is more than 40%.
The numerous indicators of nutrition deficiencies are related to inadequately nutritious and safe food, illiteracy, malpractices along with lack of nutritional knowledge and other social and behavioral issues. A healthy and supportive nutritional status, direct toward better intellect and earning of individual, which boost the social impact and macro level change.
Childhood stunting and deficiencies in iron and iodine hamper cognitive development, school achievement and adult productivity by 2.5-19.8 percent subsequently adult anemia reduces work performance in manual labor in the agriculture area and overall resultant US$ 7.6 billion annually loss for Pakistan, which corresponds to nearly 3 percent of GDP all due to poor nutritional indicators, which are preventable. Therefore, in developing countries like Pakistan, robust need is required, to do evidence base and translational research which could be easily converted into action that improves nutritional status.
Food fortification with micro-nutrients is effective, cost-efficient and medium-term approach to improve micro-nutrient status of vulnerable groups and is sustainable once established to prevent these at cheaper cost. There is need to investigate the positive effects of multiple micronutrient administration on child development along with there is dire need for more research to investigate it comprehensively at community level.
Fortified food products such as (milk, wheat, rice, oil, and other) are already in existing strategies worldwide to prevent micro-nutrient deficiencies in society which is well established and currently there are several extensive activities are implemented to prevent these hidden hunger but required results are not achieved.
On the other hand, other smart solutions are emerging to prevent these deficiencies at wider level in best possible means, among them fortified candy with multiple micronutrients is one vehicle. Confectionery products have the potential to carry the micronutrient for better delivery and doesn't significantly affect the flavour, taste and texture of the product.
The objective of the study is to determine the nutritional status, factor causing micronutrient deficiencies in pre-school children in semi-urban area of Karachi and how fortified product and enhance nutritional knowledge can bring change in nutritional indicators and understanding of nutrition in community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Placebothis group, only placebo product will be given |
| Formative messages | Experimental | Behavioral: Formative messgaesthis group will be received only daily formative messages on diet diversity, healthy and best nutrition practices |
| Fortified product | Experimental | Dietary Supplement: Fortified productthis group will be received only fortified product on alternate day up to 6 months |
| Fortified product plus | Experimental | Combination Product: Fortified product plusthis group will receive fortified product along with daily messages on diet diversity and healthy nutrition practices |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 3-5 years of age
- no medical complication
- from middle-income group within the semi-urban population
Key exclusion criteria (6 listed)
- illness/ infections (TB, Malarial drug)
- non-attendant
- severe anemia/micro nutrient deficiency
- thyroid disease
- medication/supplementation
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 |
|---|---|---|
| PlaceboIn control group, participants will receive only a placebo product | Dietary supplement | Control |
| Formative messgaesIn this group, participants will only receive daily formative messages | Behavioural | Formative messages |
| Fortified productIn this group, participants will receive fortified product on alternate day up till 8 months | Dietary supplement | Fortified product |
| Fortified product plusIn this group participants will receive fortified product on alternate day and formative messages up till 8 months | Combination product | Fortified product plus |
Primary outcome
To access the improvement in child Iron deficiency anemia
Time frame: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
change in serum Hemoglobin, serum ferritin and serum transferrin receptors
To access the improvement in children Vitamin A status
Time frame: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
Change in Serum retinol binding protein
To access the improvement in children Zinc status
Time frame: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)
Change in serum zinc
3 secondary outcomes
Difference in the children anthropocentric status
Time frame: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Effect on the household food security
Time frame: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Enhancement in the early childhood development indicators
Time frame: Base-line (at start, 0 month), Mid-line (after 4 months) and End-line (8 months at start)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: Yes
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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.
Fakhar Gulzar principal investigator
University of Veterinary and Animal Sciences, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formative messgaes, Fortified product and Fortified product plus in people with Micronutrient Deficiencies and Anemia, run by University of Veterinary and Animal Sciences, Lahore - Pakistan 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Mar 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
To access the improvement in child Iron deficiency anemia (time frame: Will be accessed at Base-line (at start), Mid-line (after 4 months) and End-line (8 months)). The study lists 3 primary outcomes in all. 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 1 Mar 2018.