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

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.

NCT Number	NCT06648018
Lead Sponsor	University Hospital, Linkoeping Collaborators: Primary Health Care Center, Region Östergötland, Linkoeping University
Conditions	Well Being
Enrollment	80 participants
Start Date	2024-10-15
Primary Completion	2024-12 (estimated)
Study Completion	2025-01 (estimated)
Updated on ClinicalTrials.gov	2024-10-18