Evaluation of Iron Bioavailability From Iron Chlorophyllin

NCT04602247 | Completed

• 1 other identifier: SIC2020
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Iron Deficiency

Keywords

iron deficiency; Iron chlorophyllin

Outcome Measures

Primary Outcomes (2)

• Fractional Iron Absorption

  Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products .Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.

  day 19

• Fractional Iron Absorption

  Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of the intervention products .Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.

  day 37

Secondary Outcomes (4)

• Hemoglobin

  Day 1, day 19 and day 37 of the study

• Plasma Ferritin

  Day 1, day 19 and day 37 of the study

• soluble transferrin receptor (sTfR)

  Day 1, day 19 and day 37 of the study

• C-Reactive Protein

  Day 1, day 19 and day 37 of the study

Study Arms (6)

SIC

EXPERIMENTAL

100 mg sodium iron chlorophyllin (SIC) containing 6 mg 57 Fe.

Dietary Supplement: SIC

SIC + AA combined

EXPERIMENTAL

100 mg sodium iron chlorophyllin (SIC) containing 6 mg 57 Fe given with 40 mg Ascorbic Acid

Dietary Supplement: SIC + AA combined

FeSO4

ACTIVE COMPARATOR

6mg of FeSO4 given as 4 mg 56Fe and 2mg 58Fe

Dietary Supplement: FeSO4

FeSO4 + AA combined

ACTIVE COMPARATOR

6mg of FeSO4 given as 4 mg 56Fe and 2mg 58Fe along with 40 mg Ascorbic Acid

Dietary Supplement: FeSO4 + AA combined

EP + FeSO4 combined

EXPERIMENTAL

100 mg of Chlorophyllin without the Magnesium central atom along with 6 mg FeSO4 as 54 Fe

Other: EP + FeSO4 combined

EP + FeSO4 + AA combined

EXPERIMENTAL

100 mg of Chlorophyllin without the Magnesium central atom along with 6 mg FeSO4 as 54 Fe along with 40 mg of Ascorbic Acid

Other: EP + FeSO4 + AA combined

Interventions

SIC DIETARY_SUPPLEMENT

Sodium Iron Chlorophyllin, whose bioavailability is to be studied

SIC

SIC + AA combined DIETARY_SUPPLEMENT

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

SIC + AA combined

FeSO4 DIETARY_SUPPLEMENT

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

FeSO4

FeSO4 + AA combined DIETARY_SUPPLEMENT

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

FeSO4 + AA combined

EP + FeSO4 combined OTHER

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

EP + FeSO4 combined

EP + FeSO4 + AA combined OTHER

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

EP + FeSO4 + AA combined

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female aged between 18-45 y old;
• SF \<80 µg/L;
• BMI 18.5-24.9 kg/m2;
• weight \<70 kg;
• signed informed consent;
• able to communicate and comprehend English language

You may not qualify if:

• anemia (Hb \<12 g/dL);
• inflammation (CRP \> 5 mg/L);
• chronic digestive, renal and/or metabolic disease;
• chronic medications (except for oral contraceptives);
• use of vitamin, mineral and pre- and/or probiotic supplements in the previous 2 weeks before study initiation and during the course of the study;
• blood transfusion, blood donation or significant blood loss over the past 4 months;
• pregnancy (tested in serum at screening) or intention to become pregnant;
• lactation up to 6 weeks before study initiation;
• earlier participation in a study using stable isotopes or participation in any clinical study within the last 30 days;
• smoking;
• unwilling to use an effective method of contraception.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

ETH Zürich, Laboratory of Human Nutrition

Zurich, Canton of Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a single-center, prospective cross-over trial in which each subject receives all test conditions. During the screening, about 2 weeks before the start of the study, women will be assessed for eligibility. Finally, 55 eligible women will be invited to participate. Each subject will complete six iron absorption studies in which they will receive supplemental iron doses of 6 mg iron.The experimental phase will last for 37 days. The labeled iron doses will be administered on days 1, 3, 5, 19, 21 and 23. Since only three isotopes are used in the study, after day 5, there will be a wait period of 14 days to allow for incorporation of the labeled iron into erythrocytes. On day 19, 21 and 23 the other three test doses are administered. Randomization of the interventional products listed above will be set up as such, to ensure that participants do not receive the same isotopes in a given week. On day 1, day 19 and day 37, a venous blood sample will be collected.

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 26, 2020
• Study Start: October 26, 2020
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

CH (1)