Comparison of Nutritional Information With Iron-succinate Supplementation in Healthy Women (Fe-Health)

Fe-minine Health and Exercise

The primary aim of the current study is to evaluate the effects of dietary nutritional advice with regards to iron rich food sources or a daily oral supplement of 100 mg ferrous iron succinate in 80 menstruating, healthy women aged 20-40 years for 8 weeks. The study will use a randomized controlled non-blinded design, and 80 healthy women aged 20-40 years whom regularly exercise will be included. Data collection will be made through online, standardized forms using the digital platform REDCap 13.1.28 (Vanderbilt University, Nashville, TN, USA). Study personnel will register laboratory and body weight results through the same system. Participants will be randomized 1:1 to either follow written dietary recommendations to increase their dietary iron intake, or to use a daily oral supplement of 100 mg of iron succinate. Study parameters are blood tests (fasting blood samples will be collected by a licensed laboratory: serum iron, serum transferrin, serum transferrin saturation, serum ferritin, and serum soluble transferrin receptor, blood status (hemoglobin, MCV, MCH, MCHC, thrombocytes, leukocytes), and plasma high-sensitivity C-reactive protein (hsCRP) and Body height and weight as well as questionnaires.

Study Overview

• Status: Enrolling by invitation
• Conditions: Well Being
• Intervention / Treatment: Behavioral: Nutritional information; Dietary supplement: Iron-succinate

Detailed Description

Aim The primary aim of the current study is to evaluate the effects of dietary nutritional advice with regards to iron rich food sources or a daily oral supplement of 100 mg ferrous iron succinate in 80 menstruating, healthy women aged 20-40 years.

Methods The study will use a randomized controlled non-blinded design, and 80 healthy women aged 20-40 years whom regularly exercise will be included. Data collection will be made through online, standardized forms using the digital platform REDCap 13.1.28 (Vanderbilt University, Nashville, TN, USA). Study personnel will register laboratory and body weight results through the same system.

Recruitment and participation criteria Individuals will be recruited through any or all of the following: at primary care center(s) in Sweden, via posters at the care center(s), via care providers during visits to the care center(s) and/or via external advertisement through social media and/or at public spaces.

Inclusion criteria will be menstruating women aged 20 to 40 years who are healthy and regularly exercise. As reimbursement, participants will receive 2000 SEK for the drawing of blood samples at the end of their study participation.

Inclusion visit

Individuals interested to participate will be booked for an inclusion visit with a study nurse during which oral and written information of the study will be provided, and a written consent will be given. Online, participants will then be asked to fill in the following information:

• A detailed online questionnaire regarding age, use of nicotine and tobacco products, and any drugs or supplements.
• A questionnaire on menstruation quantities including the number of menstruation days, the number of heavy menstruation days, and the menstrual product use, which has been shown to accurately estimate menstrual blood loss.24
• The Alcohol use disorders identification test (AUDIT)
• A food frequency questionnaire (FFQ)
• To evaluate physical activity, we will use the validated questions from the Swedish National Board of Health and Welfare,25 as well as the validated SED-GIH question of The Swedish School of Sport and Health Sciences (GIH) on sedentary behavior which was also developed with support from the Swedish National Board of Health and Welfare.26
• A questionnaire on gastrointestinal symptoms, including the number of bowel movements per week and the quality of them assessed using the Bristol stool scale (BSS). Gastrointestinal transit time can be approximated as defecation frequency, or more accurately, as stool consistency 27, and the BSS is one such questionnaire.

Body height and weight, with participants in light clothing without shoes, as well as fasting blood samples will be collected by a licensed laboratory: serum iron, serum transferrin, serum transferrin saturation, serum ferritin, and serum soluble transferrin receptor, blood status (hemoglobin, MCV, MCH, MCHC, thrombocytes, leukocytes), and plasma high-sensitivity C-reactive protein (hsCRP).

Intervention/control period Participants will be randomized 1:1 to either follow written dietary recommendations to increase their dietary iron intake, or to use a daily oral supplement of 100 mg of iron succinate.

Conclusion visit Of the above information, the following will be repeated after the conclusion of the 8 week intervention/control period: questionnaires on physical activity and gastrointestinal symptoms, the FFQ, and the drawing of blood samples.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 58185
    • Faculty of Medicine and Health Sciences Linköping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Inclusion criteria will be menstruating women aged 20 to 40 years who are healthy and regularly exercise.

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Exclusion Criteria: Significant disease affecting inflammation and/or hemoglobin levels. Inability to cooperate or to fill out questionnaires.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nutritional information; Written information about food with high iron content.	Behavioral: Nutritional information; Written nutritional information about food with high content of iron.
Experimental: 100mg iron-succinate per day as a pill.; Participants get 56 pills of 100mg iron-succinate to take one/day for 8 weeks.	Dietary supplement: Iron-succinate; 100 mg of Iron-succinate per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ferritin blood test	Change (increase) in serum ferritin levels.	From enrollment to end of test period, 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in measures of hemoglobin	Changes in measures of hemoglobin levels by blood tests	From enrollment to end of test period, 8 weeks.
Sense of well being and subjective sense of health	Sense of well being and subjective sense of health by questionnaires at start and baseline	From enrollment to end of test period, 8 weeks.

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: Linkoeping University; Primary Health Care Center, Region Östergötland
• Investigators: Principal Investigator: Fredrik H Nyström, MD PhD Professor, Linköping University, Sweden

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: September 15, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: exercise; nutrition; iron; well being
• Additional Relevant MeSH Terms: Hematinics; Ferrous succinate
• Other Study ID Numbers: Fe-minine health and exercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For ethical reasons such data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No