Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648018
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-15
Brief Title:
Comparison of Nutritional Information With Iron-succinate Supplementation in Healthy Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Fe-minine Health and Exercise
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fe-Health
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 13128 Vanderbilt University Nashville TN USA Study personnel will register laboratory and body weight results through the same system Participants will be randomized 11 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
Detailed Description:
Aim 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
Methods 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 13128 Vanderbilt University Nashville TN USA Study personnel will register laboratory and body weight results through the same system
Recruitment and participation criteria Individuals will be recruited through any or all of the following at primary care centers in Sweden via posters at the care centers via care providers during visits to the care centers andor via external advertisement through social media andor at public spaces
Inclusion criteria will be menstruating women aged 20 to 40 years who are healthy and regularly exercise As reimbursement participants will receive 2000 SEK for the drawing of blood samples at the end of their study participation
Inclusion visit
Individuals interested to participate will be booked for an inclusion visit with a study nurse during which oral and written information of the study will be provided and a written consent will be given Online participants will then be asked to fill in the following information
A detailed online questionnaire regarding age use of nicotine and tobacco products and any drugs or supplements
A questionnaire on menstruation quantities including the number of menstruation days the number of heavy menstruation days and the menstrual product use which has been shown to accurately estimate menstrual blood loss24
The Alcohol use disorders identification test AUDIT
A food frequency questionnaire FFQ
To evaluate physical activity we will use the validated questions from the Swedish National Board of Health and Welfare25 as well as the validated SED-GIH question of The Swedish School of Sport and Health Sciences GIH on sedentary behavior which was also developed with support from the Swedish National Board of Health and Welfare26
A questionnaire on gastrointestinal symptoms including the number of bowel movements per week and the quality of them assessed using the Bristol stool scale BSS Gastrointestinal transit time can be approximated as defecation frequency or more accurately as stool consistency 27 and the BSS is one such questionnaire
Body height and weight with participants in light clothing without shoes as well as 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
Interventioncontrol period Participants will be randomized 11 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
Conclusion visit Of the above information the following will be repeated after the conclusion of the 8 week interventioncontrol period questionnaires on physical activity and gastrointestinal symptoms the FFQ and the drawing of blood samples
Methods 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 13128 Vanderbilt University Nashville TN USA Study personnel will register laboratory and body weight results through the same system
Recruitment and participation criteria Individuals will be recruited through any or all of the following at primary care centers in Sweden via posters at the care centers via care providers during visits to the care centers andor via external advertisement through social media andor at public spaces
Inclusion criteria will be menstruating women aged 20 to 40 years who are healthy and regularly exercise As reimbursement participants will receive 2000 SEK for the drawing of blood samples at the end of their study participation
Inclusion visit
Individuals interested to participate will be booked for an inclusion visit with a study nurse during which oral and written information of the study will be provided and a written consent will be given Online participants will then be asked to fill in the following information
A detailed online questionnaire regarding age use of nicotine and tobacco products and any drugs or supplements
A questionnaire on menstruation quantities including the number of menstruation days the number of heavy menstruation days and the menstrual product use which has been shown to accurately estimate menstrual blood loss24
The Alcohol use disorders identification test AUDIT
A food frequency questionnaire FFQ
To evaluate physical activity we will use the validated questions from the Swedish National Board of Health and Welfare25 as well as the validated SED-GIH question of The Swedish School of Sport and Health Sciences GIH on sedentary behavior which was also developed with support from the Swedish National Board of Health and Welfare26
A questionnaire on gastrointestinal symptoms including the number of bowel movements per week and the quality of them assessed using the Bristol stool scale BSS Gastrointestinal transit time can be approximated as defecation frequency or more accurately as stool consistency 27 and the BSS is one such questionnaire
Body height and weight with participants in light clothing without shoes as well as 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
Interventioncontrol period Participants will be randomized 11 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
Conclusion visit Of the above information the following will be repeated after the conclusion of the 8 week interventioncontrol period questionnaires on physical activity and gastrointestinal symptoms the FFQ and the drawing of blood samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None