CClinicalTrials.gg
Status unknownNCT05191147PCAFEUpdated Mar 17, 2022

Prevalence of Dietary Supplement Consumption Among Pregnant Womenweeks of Pregnancy: a Cross-sectional Telephone Interview Survey

An observational study in Preference, Consumer, sponsored by University Hospital, Grenoble. Status unknown at 1 site in France. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by University Hospital, Grenoble · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Primary endpoint :

Prevalence estimation of the dietary supplement consumption among pregnant women during the first 20-25 weeks of pregnancy.

Hypothesis of the study :

The sale and consumption of dietary supplements in the general population has increased in recent years. It would be interesting to know if this is also the case for pregnant women or if they are more vigilant about their health during this period. It would also allow to identify factors associated with their consumption if it exists.

The investigators hypothesize that some women may sometimes fail to mention this supplement intake to care givers and they would like to know if these omissions are voluntary or not.

Read the detailed description

Dietary supplement are foodstuffs whose purpose is to supplement the normal diet, by constituting a concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination. There are many dietary supplement, based on plants, vitamins and minerals, or other concentrates of substances with a nutritional and physiological purpose.

Thus, the consumption of dietary supplement in pregnant women is interesting to pursue because no prevalence exists on the general consumption of food supplements in pregnant women in early pregnancy. Only studies on diet and the potential danger of supplements have been carried out. More specific studies on certain types of vitamins have also been carried out but no prevalence on general consumption has been found.

Therefore, the aim of the study is to know the extent of dietary supplementation in early pregnancy, and the associated factors in order to take it into account in the management and follow-up of patients. The investigators would also like to know the intentions and motivations of these women to consume these products.

To proceed, they will give an information sheet that will allow the collection of the telephone number, during an ultrasound (between 20 and 25 weeks of amenorrhea).Then they will call them and during the telephone interview, they will collect informations needed.

Distribution of an information sheet that will allow the collection of the telephone number of each patient coming for their second trimester ultrasound (between 20 and 25 SA). This form will be accompanied by the letter of information and non-objection which will be kept by the patient. The distribution will be done by the health professionals performing the ultrasound at the beginning or at the end of the medical appointment.

So, the primary endpoint is the proportion of women who report taking at least one dietary supplement during the first 20-25 weeks of pregnancy. This information will be collected by a phone interview.

The secondary endpoints are :

  • Describe the dietary supplements consumed during the first 20-25 weeks of pregnancy: galenic form, indication, source of information, place of purchase (pharmacy, supermarket etc.)
  • Assess whether beliefs about medication are associated with the use of dietary supplements during pregnancy, using BMQ (Belief on Medicine Questionnaire)
  • Describe the mean number of dietary supplements taken by patients in early pregnancy
  • Describe the frequency of use for each dietary supplement ('(several times a day / once a day /several times a week / once a week / once a month etc...)
02

Conditions studied

  • Preference, Consumer
03

In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Pregnant woman who come in the service for an ultrasound

Inclusion criteria

  • Aged of 18 or older
  • Pregnant woman
  • Performing a 2nd trimester ultrasound between 20 and 25 ammenorhea week
  • Informed consent signed
  • Affiliated to social security insurance or beneficiary of social security insurance

Exclusion criteria

Exclusion Criteria:

  • Subject participating in another study
  • Subject under administrative or legal supervision
  • Non-speaking french
  • Opposing their participation in the research
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • Dietary supplementDietary supplement

    We will study dietary supplement consumption among pregnant women

06

What researchers measure

Primary outcomes

  1. the proportion of women who report taking at least one dietary supplement during the first 20-25 weeks of pregnancy

    what is the percentage of pregnant women who take dietary supplement

    Time frame: 1 month

Secondary outcomes

  1. Describe the dietary supplements consumed during the first 20-25 weeks of pregnancy

    Which galenic form, indication, source of information, place of purchase (pharmacy, supermarket etc.)

    Time frame: 1 month

  2. Assess whether beliefs about medication are associated with the use of dietary supplements during pregnancy

    using BMQ (Belief on Medicine Questionnaire)

    Time frame: 1 month

  3. Describe the mean number of dietary supplements taken by patients in early pregnancy

    How many dietary supplement pregnant women take on a daily basis

    Time frame: 1 month

  4. Describe the frequency of use for each dietary supplement

    Several times a day / once a day /several times a week / once a week / once a month etc.

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • University Hospital Grenoble
    Grenoble, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05191147
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Jan 13, 2022
Start date
Jan 1, 2022
Primary completion
Apr 10, 2022 (estimated)
Completion
May 10, 2022 (estimated)
Last update
Mar 17, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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