Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C

NCT03762148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-07-25

No results posted yet for this study

Summary

Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO.

In a recent iron absorption study in adult women with low iron stores in our lab (publication under review), we found that 15 g of GOS given with an iron supplement in the form of iron fumarate acutely increased iron absorption when given with water and a bread based meal. The dose of 15 g of GOS was tolerated well by the participants. As a follow up to the study mentioned above, we want to investigate: 1) if acute iron absorption is affected by lower doses of GOS; 2) whether this acute effect occurs for other commonly used iron compounds as well, such as iron sulphate and iron phosphate; and 3) if there are potential interactions on absorption with other enhancers of iron absorption, such as vitamin c.

Conditions

  • Iron-deficiency

Interventions

DIETARY_SUPPLEMENT

ferrous fumarate

nutritional iron (14 mg) supplement in form of ferrous fumarate

DIETARY_SUPPLEMENT

ferrous sulphate

nutritional iron (14 mg) supplement in form of ferrous sulphate

DIETARY_SUPPLEMENT

ferric pyrophosphate

nutritional iron (14 mg) supplement in form of ferric pyrophosphate

DIETARY_SUPPLEMENT

ferrous fumarate + 3.5 g GOS

nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS)

DIETARY_SUPPLEMENT

ferrous fumarate + 7 g GOS

nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS)

DIETARY_SUPPLEMENT

ferrous sulphate + 15 g GOS

nutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS)

DIETARY_SUPPLEMENT

ferrous fumarate + Vitamin C

nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C

DIETARY_SUPPLEMENT

ferric pyrophosphate + 15 g GOS

nutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS)

DIETARY_SUPPLEMENT

ferrous fumarate + 7 g GOS + Vitamin C

nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C

Sponsors & Collaborators

  • Burgerstein Vitamine

    collaborator INDUSTRY
  • Isabelle Herter-Aeberli

    lead OTHER

Principal Investigators

  • Isabelle Herter-Aeberli, Dr. · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-06-11
Completion
2019-06-11

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03762148 on ClinicalTrials.gov