ClinicalTrials.Veeva

Menu

The Effects of Iron and Omega-3 Fatty Acid Supplementation on Cognition and Immune Function in Iron Deficient Children (FeFA)

N

North-West University, South Africa

Status

Completed

Conditions

Anemia
Iron Deficiency

Treatments

Dietary Supplement: DHA and EPA Fish Oil capsule
Other: Placebo tablet
Dietary Supplement: Iron tablet
Other: Placebo capsule

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01092377
FeFA study 2010

Details and patient eligibility

About

The aim of this study is to determine if providing iron and a mixture of DHA and EPA, alone and in combination, to children with iron deficiency and poor n-3 fatty acid intake will improve their cognitive performance, activity levels and immune system.

Additionally, the effects on iron and fatty acid status, and gut microbiota, will be assessed.

Full description

In populations of low socio economic status, such as found in South Africa, iron deficiency coexisting with a low intake of n-3 fatty acids could synergistically compromise both the intellectual performance and immune system of children.

Therefore, specific cognitive processes (domains) and specific immunization status markers and immune function modulators, that have been found to be affected by iron and n-3 fatty acid deficiency in children in previous studies will be assessed.

This will be the first human study that assesses the interactions of iron and n-3 fatty acid supplementation to iron deficient children in a two-by-two factorial, randomized, double-blind, placebo-controlled trial.

Enrollment

320 patients

Sex

All

Ages

6 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: 6-10 years
  • Iron deficiency (Serum ferritin < 20 µg/L or zinc protoporphyrin > 70 µmol/mol heme in washed erythrocytes or TfR > 8.3 mg/L) with no or mild anaemia

Exclusion criteria

  • Chronic illness
  • Severe anemia (Hb < 80 g/L)
  • Use of iron or n-3 fatty acid containing supplements

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

320 participants in 4 patient groups, including a placebo group

DHA/EPA capsules and iron tablet
Experimental group
Treatment:
Dietary Supplement: Iron tablet
Dietary Supplement: DHA and EPA Fish Oil capsule
DHA/EPA and placebo tablet
Experimental group
Treatment:
Other: Placebo tablet
Dietary Supplement: DHA and EPA Fish Oil capsule
placebo capsules & placebo tablet
Placebo Comparator group
Treatment:
Other: Placebo capsule
Dietary Supplement: Iron tablet
Other: Placebo tablet
iron tablet and placebo capsules
Experimental group
Treatment:
Other: Placebo capsule

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems