NCT03438942

Brief Summary

The aim of the study is to determine the factors affecting the bioavailability of iron and folic acid during the simultaneous use of iron supplements and folic acid supplements in non-pregnant women of childbearing age.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

February 13, 2018

Last Update Submit

April 4, 2022

Conditions

Nutrition Disorders

Keywords

ironfolatechildbearing agebioavailability

Outcome Measures

Primary Outcomes (4)

  • folic acid concentrations at baseline

    blood folic acid concentrations at baseline

    At the baseline

  • folic acid concentrations after 3 months of treatment

    blood folic acid concentrations after 3 months of treatment

    after 3 months of treatment

  • iron concentrations at baseline

    blood iron concentrations at baseline

    At the baseline

  • iron concentrations after 3 months of treatment

    blood ron concentrations after 3 months of treatment

    after 3 months of treatment

Secondary Outcomes (17)

  • blood pressure

    At the baseline

  • body mass

    At the baseline

  • body height

    At the baseline

  • Body % fat

    At the baseline

  • Body % muscle

    At the baseline

  • +12 more secondary outcomes

Study Arms (2)

Folic acid and iron supplementation

EXPERIMENTAL

Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months

Dietary Supplement: Folic acid and iron supplementation

Control group

ACTIVE COMPARATOR

Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months

Dietary Supplement: Control group

Interventions

Folic acid and iron supplementationDIETARY_SUPPLEMENT

Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months

Folic acid and iron supplementation
Control groupDIETARY_SUPPLEMENT

Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months

Control group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale gender based on self-representation
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18 to 35 years
  • stable body weight (\< 3 kg self-reported change during the previous three months)
  • written informed consent to participate in the study,
  • regular menstrual period;
  • regular diet

You may not qualify if:

  • history of use of any dietary supplements within the one month prior to the study containing iron or folic acid
  • clinically relevant acute or chronic inflammatory disease in the respiratory, gastrointestinal or genitourinary system or in the mouth, throat, paranasal sinuses and / or connective tissue disease, arthritis;
  • simultaneous participation in a study that affects body weight or use of diet / medication / nutritional behaviors affecting body weight;
  • a history of infection in the month prior to the study
  • nicotine, drug or alcohol abuse
  • vegetarian diet;
  • pregnancy or lactation
  • other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Life Sciences

Poznan, 60-624, Poland

Location

MeSH Terms

Conditions

Nutrition Disorders

Interventions

Folic AcidControl Groups

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Joanna Suliburska, Ass Prof

    Institute of Human Nutrition and Dietetics, Poznań University of Life Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 20, 2018

Study Start

September 30, 2018

Primary Completion

September 30, 2021

Study Completion

December 30, 2021

Last Updated

April 5, 2022

Record last verified: 2022-04

Locations

PL(1)