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ENROLLING BY INVITATION
NCT06648018
NA

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

Sponsor: University Hospital, Linkoeping

View on ClinicalTrials.gov

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.

Official title: Fe-minine Health and Exercise

Key Details

Gender

FEMALE

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-10-15

Completion Date

2025-01

Last Updated

2024-10-18

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Nutritional information

Written nutritional information about food with high content of iron.

DIETARY_SUPPLEMENT

Iron-succinate

100 mg of Iron-succinate per day.

Locations (1)

Faculty of Medicine and Health Sciences Linköping University

Linköping, Sweden