Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C
- Conditions
- Iron-deficiency
- Interventions
- Dietary Supplement: ferrous sulphateDietary Supplement: ferric pyrophosphateDietary Supplement: ferrous fumarate + Vitamin CDietary Supplement: ferrous fumarate + 7 g GOSDietary Supplement: ferrous sulphate + 15 g GOSDietary Supplement: ferric pyrophosphate + 15 g GOSDietary Supplement: ferrous fumarateDietary Supplement: ferrous fumarate + 7 g GOS + Vitamin CDietary Supplement: ferrous fumarate + 3.5 g GOS
- Registration Number
- NCT03762148
- Lead Sponsor
- Isabelle Herter-Aeberli
- Brief 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.
- Detailed Description
Iron is an important mineral in our body and fulfills essential functions such as for example oxygen transport from the lungs to the tissues. Iron deficiency is still the most common and widespread nutritional disorder in the world according to WHO. Common iron supplements all have their limitations in terms of availability and compatibility. Prebiotic fibers, such as galacto-oligosaccharides (GOS), selectively enhance growth of beneficial colonic bacteria. Prebiotics in general enhance the production of short-chain fatty acids (SCFAs) and thereby decrease luminal pH. Through the reduction in pH, prebiotics can enhance absorption of minerals such as calcium and magnesium and they have been proposed to potentially improve iron absorption.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 46
- Female, 18 to 45 years old
- SF levels <30 µg/L
- Normal body Mass Index (18.5-24.9 kg/m2)
- Body weight <70 kg
- Signed informed consent
- Severe anaemia (Hb < 80 g/L)
- Elevated CRP >10.0 mg/L
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
- Continuous/long-term use of medication during the whole studies (except for contraceptives)
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration, including pre- and-or probiotics supplements (excluding foods and beverages with life cultures such as yoghurt, raw milk cheese and kombucha)
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
- Difficulties with blood sampling
- Use of antibiotics over the past month
- Known hypersensitivity to iron supplements in the given amount, GOS, or lactose
- Women who are pregnant or breast feeding
- Women who intend become pregnant during the course of the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, inject-able, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
- Known or suspected non-compliance, drug or alcohol (more than 2 drinks/day) abuse -
- Smokers (> 1 cigarette per week)
- Inability to follow the procedures of the study, e.g. due to language problems, self-- reported psychological disorders, etc. of the participant
- Enrollment of the investigator, his/her family members, employees and other dependent persons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ferrous sulphate ferrous sulphate labelled iron as ferrous sulphate ferric pyrophosphate ferric pyrophosphate labelled iron as ferric pyrophosphate ferrous fumarate + Vitamin C ferrous fumarate + Vitamin C labelled iron as ferrous fumarate + Vitamin C ferrous fumarate + 7 g GOS ferrous fumarate + 7 g GOS labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS ferrous sulphate + 15 g GOS ferrous sulphate + 15 g GOS labelled iron as ferrous sulphate + prebiotics in the form of 15 g GOS ferric pyrophosphate + 15 g GOS ferric pyrophosphate + 15 g GOS labelled iron as ferric pyrophosphate + prebiotics in the form of 15 g GOS ferrous fumarate ferrous fumarate labelled iron as ferrous fumarate ferrous fumarate + 7 g GOS + Vitamin C ferrous fumarate + 7 g GOS + Vitamin C labelled iron as ferrous fumarate + prebiotics in the form of 7 g GOS + Vitamin C ferrous fumarate + 3.5 g GOS ferrous fumarate + 3.5 g GOS labelled iron as ferrous fumarate + prebiotics in the form of 3.5 g GOS
- Primary Outcome Measures
Name Time Method fractional iron absorption 2 months Fractional iron absorption will be calculated based on the shift of the iron isotope ratios in the collected blood samples after the administration of several isotopically labelled iron supplements.Fractional iron absorption will be measured as erythrocyte incorporation of the naturally occurring iron forms with different masses used to label the iron supplements.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Human Nutrition Laboratory, ETH Zurich
🇨🇭Zurich, Switzerland