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

Condition(s) studied

Investigational drug(s) / intervention(s)

Nutritional information: Written nutritional information about food with high content of iron.

Iron-succinate: 100 mg of Iron-succinate per day.

Study 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.

Eligibility

Primary outcome measure(s)

• Ferritin blood test — From enrollment to end of test period, 8 weeks.
  Change (increase) in serum ferritin levels.

Trial sites (1)

More University Hospital, Linkoeping trials in Sweden