Comparison of Nutritional Information With Iron-succinate Supplementation in Healthy Women

NCT06648018 | Enrolling By Invitation

• 1 other identifier: Fe-minine health and exercise
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Well Being

Keywords

nutrition; exercise; iron; well being

Outcome Measures

Primary Outcomes (1)

• Ferritin blood test

  Change (increase) in serum ferritin levels.

  From enrollment to end of test period, 8 weeks.

Secondary Outcomes (2)

• Changes in measures of hemoglobin

  From enrollment to end of test period, 8 weeks.

• Sense of well being and subjective sense of health

  From enrollment to end of test period, 8 weeks.

Study Arms (2)

Nutritional information

ACTIVE COMPARATOR

Written information about food with high iron content.

Behavioral: Nutritional information

100mg iron-succinate per day as a pill.

EXPERIMENTAL

Participants get 56 pills of 100mg iron-succinate to take one/day for 8 weeks.

Dietary Supplement: Iron-succinate

Interventions

Nutritional information BEHAVIORAL

Written nutritional information about food with high content of iron.

Nutritional information

Iron-succinate DIETARY_SUPPLEMENT

100 mg of Iron-succinate per day.

100mg iron-succinate per day as a pill.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Women who are menstruating. This is a trial of potentially low ferritin levels in menstruating women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Primary Health Care Center, Region Östergötland: collaborator
• Linkoeping University: collaborator

Study Sites (1)

Faculty of Medicine and Health Sciences Linköping University

Linköping, 58185, Sweden

Location

MeSH Terms

Conditions

Motor Activity

Interventions

ferrous succinate

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Fredrik H Nyström, MD PhD Professor

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD full professor, senior consultant in internal medicine

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: October 18, 2024
• Study Start: October 15, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)