Evaluation of Iron Bioavailability From Iron Chlorophyllin

NCT04602247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-03-26

No results posted yet for this study

Summary

The overall objective of this study is to evaluate the iron absorption from iron chlorophyllin. Iron deficiency is a public health problem in both developing and industrialized countries. There are several approaches to combat iron deficiency. Most supplements in the present day, to address the problem of iron deficiency, are in the form of iron salts, known as ferrous salts, especially ferrous sulfate. However, we can only usually absorb about 20% of the total iron content in ferrous sulfate. The common strategy of food supplement companies is to increase the amount of iron in the supplements to compensate for the low absorption rate. However, this often causes gastrointestinal side effects. In the present study, we would like to measure the iron bioavailability from sodium iron chlorophyllin, which made up from ferrous salts and chlorophyllin and where we hypothesize that it is absorbed via a different pathway than ferrous sulfate. Via this mechanism, we further hypothesize that sodium iron chlorophyllin will therefore have an enhanced bioavailability and more favorable side effect profile than ferrous sulfate and other iron salts.

Conditions

Interventions

DIETARY_SUPPLEMENT

SIC

Sodium Iron Chlorophyllin, whose bioavailability is to be studied

DIETARY_SUPPLEMENT

SIC + AA combined

Sodium Iron Chlorophyllin and ascorbic acid. The ascorbic acid should not have an effect on Sodium Iron Chlorophyllin

DIETARY_SUPPLEMENT

FeSO4

Ferrous sulfate serves as a positive control, whose iron bioavailability is known

DIETARY_SUPPLEMENT

FeSO4 + AA combined

Ferrous sulfate serves as a positive control and the addition of ascorbic acid, further enhances its bioavailability

OTHER

EP + FeSO4 combined

Chlorophyllin with an empty porphyrin ring, given along with FeSO4 to study if there is an incorporation of Fe into the porphyrin ring as it passes the gastric system

OTHER

EP + FeSO4 + AA combined

Chlorophyllin with an empty porphyrin ring, given along with FeSO4 to study if there is an incorporation of Fe into the porphyrin ring as it passes the gastric system. Ascorbic acid is given along with the intervention to see if there is any difference in the fractional iron absorption when compared to EP+ FeSO4

Sponsors & Collaborators

  • Swiss Federal Institute of Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2020-12-14
Completion
2020-12-14

Countries

  • Switzerland

Study Locations

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Entities

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 NCT04602247 on ClinicalTrials.gov