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

NCT06648018 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-10-18

No results posted yet for this 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.

Conditions

  • Well Being

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.

Sponsors & Collaborators

  • Primary Health Care Center, Region Östergötland

    collaborator UNKNOWN

  • Linkoeping University

    collaborator OTHER_GOV

  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Fredrik H Nyström, MD PhD Professor · Linkoeping University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06648018 on ClinicalTrials.gov