Cognitive Ability, GeneralNUPICONCT01504633
Nutrigenomics, PUFA, Iron and Cognition Amongst Under-two-year-old Indonesian Children
A study testing DHA/EPA and iron supplementation in people with Cognitive Ability, General, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Rationale: Review on the positive effect of long chain polyunsaturated fatty acids (LCPUFA), especially docosahexanoic acid (DHA), supplementation on cognitive function in human using randomized controlled trials (RCTs) showed that results in RCTs were mixed and inconsistent. Read more about this study
- Who is it for?
- Ages 12 to 16 monthsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Ability, General
- What is being tested?
- DHA/EPA and iron supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIndonesia
- Study dates
- Dec 2011to Dec 2014
- 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 12 to 16 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child aged 12 to 17months old
- Both father and mother of Sasak ethnicity
- Currently breastfed
Who cannot join
- Birth weight <2500 grams (LBW)
- Congenital malformation and/or disorder that interfered with adequate functioning in daily life
- Hemoglobin value below 70 g/L
- Malaria
- Maternal depression
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
SEAMEO Regional Center for Food and Nutrition (RECFON) University of Indonesia
Jakarta, DKI Jakarta, 10430
About this study
Official title: Can NUtrigenomics / Nutrigenetics Help Explain the Mixed Results on Effect of LCPUFA (DHA) and Iron on Child COgnition?
Rationale: Review on the positive effect of long chain polyunsaturated fatty acids (LCPUFA), especially docosahexanoic acid (DHA), supplementation on cognitive function in human using randomized controlled trials (RCTs) showed that results in RCTs were mixed and inconsistent. It has been suggested that the effect may be subtle, which is currently difficult to detect, but could be significant, or there may be individual variation which mediate the effect.
Objectives: This study aims to assess gene-nutrient inter-relation in explaining the effect of LCPUFAs i.e. DHA and/or iron on cognitive functioning of children <24mo in Indonesia. Specifically the study's objectives are: (1) to assess effect of LCPUFA (as DHA oil) and iron (as iron supplement) in altering gene expressions, and (2) to assess the mediating effect of genes involved in fatty acid and iron metabolism in improving serum LCPUFA, alpha-linolenic acids (ALA), DHA and cognitive function.
Read more
Study design and study population: The study is a double-blind randomized controlled trial with children aged less than 24 months (window of opportunity). The study area is in East Lombok district, in West Nusa Tenggara province, Indonesia where nutrient intake including iron and presumably LCPUFA, is not optimal.
Intervention: The study is an intervention study, consisting of four groups: DHA, iron, DHA+iron, and placebo (60 subjects/group = 240 subjects in total). Capsule containing 100mg/d DHA or its placebo and syrup containing 16mg/d iron will be given daily for 24 weeks. Before and after the intervention child cognition (as Bayley Mental Developmental Index or MDI score), serum PUFA level, iron status (haemoglobin, transferrin receptor, ferritin), inflammation status (CRP, AGP), gene expression profiles, and potential confounders of child cognition such as lengt-for-age, weight-for-length, and weight-for-age Z-scores, stimulation/home environment, maternal characteristics will be collected.
Study outcome: The primary study outcomes will be cognitive score (as Bayley Mental Developmental Index or MDI score) and gene expression profiles. Secondary study outcomes will be serum PUFA level, iron status (haemoglobin, TfR, ferritin).
Nature and extent of the burden and risks benefit and group relatedness:
Subjects, who will be included into the study will invest 14 hours. The consumption of iron is not associated with any increased risk of iron overload both for infectious (including malaria) and chronic diseases nor consumption of n-3 fatty acids EPA and DHA exceed the US Food and Drug Administrator (FDA) Generally Recognized as Save (GRAS) limit. Venous blood of 5 mL will be drawn at baseline and endline. During screening, children with severe anaemia (Hb<70g/L) will be excluded from the study and referred to the local public health center for further treatment.
- Conditions
- Cognitive Ability, General
- Being tested
- DHA/EPA and iron supplementation
- Keywords
- cognitive function, omega-3 PUFA (DHA), iron, nutrigenomics, under-two year old children, Indonesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA/EPA and iron supplementationDietary supplement
24-week supplementation consisting of daily dosage of DHA/EPA or placebo capsule and iron/placebo syrup Capsule: DHA/EPA (100mg DHA + 20mg per day) or placebo Syrup: Fe syrup (16mg elemental iron per day) or placebo
| Study group | Role | What they receive |
|---|---|---|
| DHA+EPA Group | Experimental | DHA/EPA capsule (100mg DHA + 20mg) and placebo syrup per day Receives: Dietary Supplement: DHA/EPA and iron supplementation |
| Fe Group | Experimental | Placebo capsule and Fe syrup (16mg elemental iron) per day Receives: Dietary Supplement: DHA/EPA and iron supplementation |
| DHA/EPA+Fe Group | Experimental | DHA/EPA capsule (100mg DHA + 20mg) and Fe syrup (16mg elemental iron) per day Receives: Dietary Supplement: DHA/EPA and iron supplementation |
| Placebo Group | Experimental | Placebo capsule and placebo syrup Receives: Dietary Supplement: DHA/EPA and iron supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cognitive function (MDI score)
Mental Developmental Index (MDI) score of Bayley Scale of Infant Development (BSID)
Measured: within 24 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cognitive Ability, GeneralStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University
- Responsible party
- Principal investigator, Umi Fahmida, Universitas Indonesia
- Investigators
- Umi Fahmida, PhD, Principal investigator, SEAMEO Regional Center for Food and Nutrition (RECFON) University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504633
- Sponsor's protocol ID
- NUPICO-Indonesia
- Acronym
- NUPICO
- Status last verified
- Feb 2014
- First submitted
- 31 Dec 2011
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Arterburn LM, Hall EB, Oken H. Distribution, interconversion, and dose response of n-3 fatty acids in humans. Am J Clin Nutr. 2006 Jun;83(6 Suppl):1467S-1476S. doi: 10.1093/ajcn/83.6.1467S.
PubMed 16841856Bouwens M, van de Rest O, Dellschaft N, Bromhaar MG, de Groot LC, Geleijnse JM, Muller M, Afman LA. Fish-oil supplementation induces antiinflammatory gene expression profiles in human blood mononuclear cells. Am J Clin Nutr. 2009 Aug;90(2):415-24. doi: 10.3945/ajcn.2009.27680. Epub 2009 Jun 10.
PubMed 19515734Bouwens M, Grootte Bromhaar M, Jansen J, Muller M, Afman LA. Postprandial dietary lipid-specific effects on human peripheral blood mononuclear cell gene expression profiles. Am J Clin Nutr. 2010 Jan;91(1):208-17. doi: 10.3945/ajcn.2009.28586. Epub 2009 Nov 18.
PubMed 19923369Cunnane SC, McAdoo KR. Iron intake influences essential fatty acid and lipid composition of rat plasma and erythrocytes. J Nutr. 1987 Sep;117(9):1514-9. doi: 10.1093/jn/117.9.1514.
PubMed 3116180El-khayat H, Shaaban S, Emam EK, Elwakkad A. Cognitive functions in protein-energy malnutrition: in relation to long chain-polyunsaturated fatty acids. Pak J Biol Sci. 2007 Jun 1;10(11):1773-81. doi: 10.3923/pjbs.2007.1773.1781.
PubMed 19086537Idjradinata P, Pollitt E. Reversal of developmental delays in iron-deficient anaemic infants treated with iron. Lancet. 1993 Jan 2;341(8836):1-4. doi: 10.1016/0140-6736(93)92477-b.
PubMed 7678046Koletzko B, Demmelmair H, Schaeffer L, Illig T, Heinrich J. Genetically determined variation in polyunsaturated fatty acid metabolism may result in different dietary requirements. Nestle Nutr Workshop Ser Pediatr Program. 2008;62:35-44; discussion 44-9. doi: 10.1159/000146246.
PubMed 18626191Kwik-Uribe CL, Gietzen D, German JB, Golub MS, Keen CL. Chronic marginal iron intakes during early development in mice result in persistent changes in dopamine metabolism and myelin composition. J Nutr. 2000 Nov;130(11):2821-30. doi: 10.1093/jn/130.11.2821.
PubMed 11053527McCann JC, Ames BN. Is docosahexaenoic acid, an n-3 long-chain polyunsaturated fatty acid, required for development of normal brain function? An overview of evidence from cognitive and behavioral tests in humans and animals. Am J Clin Nutr. 2005 Aug;82(2):281-95. doi: 10.1093/ajcn.82.2.281.
PubMed 16087970McCann JC, Ames BN. An overview of evidence for a causal relation between iron deficiency during development and deficits in cognitive or behavioral function. Am J Clin Nutr. 2007 Apr;85(4):931-45. doi: 10.1093/ajcn/85.4.931.
PubMed 17413089Murray-Kolb LE, Beard JL. Iron deficiency and child and maternal health. Am J Clin Nutr. 2009 Mar;89(3):946S-950S. doi: 10.3945/ajcn.2008.26692D. Epub 2009 Jan 21.
PubMed 19158210Oloyede OB, Folayan AT, Odutuga AA. Effects of low-iron status and deficiency of essential fatty acids on some biochemical constituents of rat brain. Biochem Int. 1992 Aug;27(5):913-22.
PubMed 1417923Smuts CM, Tichelaar HY, van Jaarsveld PJ, Badenhorst CJ, Kruger M, Laubscher R, Mansvelt EP, Benade AJ. The effect of iron fortification on the fatty acid composition of plasma and erythrocyte membranes in primary school children with and without iron deficiency. Prostaglandins Leukot Essent Fatty Acids. 1995 Jan;52(1):59-67. doi: 10.1016/0952-3278(95)90098-5.
PubMed 7708822Stangl GI, Kirchgessner M. Different degrees of moderate iron deficiency modulate lipid metabolism of rats. Lipids. 1998 Sep;33(9):889-95. doi: 10.1007/s11745-998-0285-8.
PubMed 9778136Rajilic-Stojanovic M, Heilig HG, Molenaar D, Kajander K, Surakka A, Smidt H, de Vos WM. Development and application of the human intestinal tract chip, a phylogenetic microarray: analysis of universally conserved phylotypes in the abundant microbiota of young and elderly adults. Environ Microbiol. 2009 Jul;11(7):1736-51. doi: 10.1111/j.1462-2920.2009.01900.x. Epub 2009 Mar 11.
PubMed 19508560
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can NUtrigenomics / Nutrigenetics Help Explain the Mixed Results on Effect of LCPUFA (DHA) and Iron on Child COgnition?
- ClinicalTrials.gov ID
- NCT01504633
- Acronym / sponsor ID
- NUPICO / NUPICO-Indonesia
- Conditions
- Cognitive Ability, General
- Keywords
- cognitive function, omega-3 PUFA (DHA), iron, nutrigenomics, under-two year old children, Indonesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Wageningen University
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 5 Jan 2012 (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.
Rationale: Review on the positive effect of long chain polyunsaturated fatty acids (LCPUFA), especially docosahexanoic acid (DHA), supplementation on cognitive function in human using randomized controlled trials (RCTs) showed that results in RCTs were mixed and inconsistent. It has been suggested that the effect may be subtle, which is currently difficult to detect, but could be significant, or there may be individual variation which mediate the effect.
Objectives: This study aims to assess gene-nutrient inter-relation in explaining the effect of LCPUFAs i.e. DHA and/or iron on cognitive functioning of children <24mo in Indonesia. Specifically the study's objectives are: (1) to assess effect of LCPUFA (as DHA oil) and iron (as iron supplement) in altering gene expressions, and (2) to assess the mediating effect of genes involved in fatty acid and iron metabolism in improving serum LCPUFA, alpha-linolenic acids (ALA), DHA and cognitive function.
Study design and study population: The study is a double-blind randomized controlled trial with children aged less than 24 months (window of opportunity). The study area is in East Lombok district, in West Nusa Tenggara province, Indonesia where nutrient intake including iron and presumably LCPUFA, is not optimal.
Intervention: The study is an intervention study, consisting of four groups: DHA, iron, DHA+iron, and placebo (60 subjects/group = 240 subjects in total). Capsule containing 100mg/d DHA or its placebo and syrup containing 16mg/d iron will be given daily for 24 weeks. Before and after the intervention child cognition (as Bayley Mental Developmental Index or MDI score), serum PUFA level, iron status (haemoglobin, transferrin receptor, ferritin), inflammation status (CRP, AGP), gene expression profiles, and potential confounders of child cognition such as lengt-for-age, weight-for-length, and weight-for-age Z-scores, stimulation/home environment, maternal characteristics will be collected.
Study outcome: The primary study outcomes will be cognitive score (as Bayley Mental Developmental Index or MDI score) and gene expression profiles. Secondary study outcomes will be serum PUFA level, iron status (haemoglobin, TfR, ferritin).
Nature and extent of the burden and risks benefit and group relatedness:
Subjects, who will be included into the study will invest 14 hours. The consumption of iron is not associated with any increased risk of iron overload both for infectious (including malaria) and chronic diseases nor consumption of n-3 fatty acids EPA and DHA exceed the US Food and Drug Administrator (FDA) Generally Recognized as Save (GRAS) limit. Venous blood of 5 mL will be drawn at baseline and endline. During screening, children with severe anaemia (Hb<70g/L) will be excluded from the study and referred to the local public health center for further treatment.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DHA+EPA Group | Experimental | Dietary Supplement: DHA/EPA and iron supplementationDHA/EPA capsule (100mg DHA + 20mg) and placebo syrup per day |
| Fe Group | Experimental | Dietary Supplement: DHA/EPA and iron supplementationPlacebo capsule and Fe syrup (16mg elemental iron) per day |
| DHA/EPA+Fe Group | Experimental | Dietary Supplement: DHA/EPA and iron supplementationDHA/EPA capsule (100mg DHA + 20mg) and Fe syrup (16mg elemental iron) per day |
| Placebo Group | Experimental | Dietary Supplement: DHA/EPA and iron supplementationPlacebo capsule and placebo syrup |
Who may qualify
- Ages
- 12 to 16 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child aged 12 to 17months old
- Both father and mother of Sasak ethnicity
- Currently breastfed
Key exclusion criteria (5 listed)
- Birth weight <2500 grams (LBW)
- Congenital malformation and/or disorder that interfered with adequate functioning in daily life
- Hemoglobin value below 70 g/L
- Malaria
- Maternal depression
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 |
|---|---|---|
| DHA/EPA and iron supplementation24-week supplementation consisting of daily dosage of DHA/EPA or placebo capsule and iron/placebo syrup Capsule: DHA/EPA (100mg DHA + 20mg per day) or placebo Syrup: Fe syrup (16mg elemental iron per day) or placebo | Dietary supplement | DHA+EPA Group, DHA/EPA+Fe Group, Fe Group, Placebo Group |
Primary outcome
change in cognitive function (MDI score)
Time frame: within 24 weeks after start of intervention
Mental Developmental Index (MDI) score of Bayley Scale of Infant Development (BSID)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
- Background: PubMed 16841856Arterburn LM, Hall EB, Oken H. Distribution, interconversion, and dose response of n-3 fatty acids in humans. Am J Clin Nutr. 2006 Jun;83(6 Suppl):1467S-1476S. doi: 10.1093/ajcn/83.6.1467S.
- Background: PubMed 19515734Bouwens M, van de Rest O, Dellschaft N, Bromhaar MG, de Groot LC, Geleijnse JM, Muller M, Afman LA. Fish-oil supplementation induces antiinflammatory gene expression profiles in human blood mononuclear cells. Am J Clin Nutr. 2009 Aug;90(2):415-24. doi: 10.3945/ajcn.2009.27680. Epub 2009 Jun 10.
- Background: PubMed 19923369Bouwens M, Grootte Bromhaar M, Jansen J, Muller M, Afman LA. Postprandial dietary lipid-specific effects on human peripheral blood mononuclear cell gene expression profiles. Am J Clin Nutr. 2010 Jan;91(1):208-17. doi: 10.3945/ajcn.2009.28586. Epub 2009 Nov 18.
- Background: PubMed 3116180Cunnane SC, McAdoo KR. Iron intake influences essential fatty acid and lipid composition of rat plasma and erythrocytes. J Nutr. 1987 Sep;117(9):1514-9. doi: 10.1093/jn/117.9.1514.
- Background: PubMed 19086537El-khayat H, Shaaban S, Emam EK, Elwakkad A. Cognitive functions in protein-energy malnutrition: in relation to long chain-polyunsaturated fatty acids. Pak J Biol Sci. 2007 Jun 1;10(11):1773-81. doi: 10.3923/pjbs.2007.1773.1781.
- Background: PubMed 7678046Idjradinata P, Pollitt E. Reversal of developmental delays in iron-deficient anaemic infants treated with iron. Lancet. 1993 Jan 2;341(8836):1-4. doi: 10.1016/0140-6736(93)92477-b.
- Background: PubMed 18626191Koletzko B, Demmelmair H, Schaeffer L, Illig T, Heinrich J. Genetically determined variation in polyunsaturated fatty acid metabolism may result in different dietary requirements. Nestle Nutr Workshop Ser Pediatr Program. 2008;62:35-44; discussion 44-9. doi: 10.1159/000146246.
- Background: PubMed 11053527Kwik-Uribe CL, Gietzen D, German JB, Golub MS, Keen CL. Chronic marginal iron intakes during early development in mice result in persistent changes in dopamine metabolism and myelin composition. J Nutr. 2000 Nov;130(11):2821-30. doi: 10.1093/jn/130.11.2821.
- Background: PubMed 16087970McCann JC, Ames BN. Is docosahexaenoic acid, an n-3 long-chain polyunsaturated fatty acid, required for development of normal brain function? An overview of evidence from cognitive and behavioral tests in humans and animals. Am J Clin Nutr. 2005 Aug;82(2):281-95. doi: 10.1093/ajcn.82.2.281.
- Background: PubMed 17413089McCann JC, Ames BN. An overview of evidence for a causal relation between iron deficiency during development and deficits in cognitive or behavioral function. Am J Clin Nutr. 2007 Apr;85(4):931-45. doi: 10.1093/ajcn/85.4.931.
- Background: PubMed 19158210Murray-Kolb LE, Beard JL. Iron deficiency and child and maternal health. Am J Clin Nutr. 2009 Mar;89(3):946S-950S. doi: 10.3945/ajcn.2008.26692D. Epub 2009 Jan 21.
- Background: PubMed 1417923Oloyede OB, Folayan AT, Odutuga AA. Effects of low-iron status and deficiency of essential fatty acids on some biochemical constituents of rat brain. Biochem Int. 1992 Aug;27(5):913-22.
- South East Asia Ministers of Education Organization, Regional Center for Food and Nutrition, University of IndonesiaLink provided by the sponsor.
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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.
Umi Fahmida, PhD principal investigator
SEAMEO Regional Center for Food and Nutrition (RECFON) University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA/EPA and iron supplementation in people with Cognitive Ability, General, run by Universitas Indonesia at 1 site in Indonesia.
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 5 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 26 Feb 2014. 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 Indonesia. 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?
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?
change in cognitive function (MDI score) (time frame: within 24 weeks after start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01504633, which also lists 17 linked publications.
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 26 Feb 2014.