About this trial
Our study aims to explore the influence of dietary chromium supplementation in the form of chromium picolinate, at different doses (200 µg and 400 µg per day), on the health of pregnant women with gestational diabetes. This study will also provide more information on the safety of this type of supplementation during pregnancies complicated by gestational diabetes mellitus.
The main questions it aims to answer are:
* Does chromium supplementation at various doses in women with gestational diabetes mellitus truly influence their glucido-lipidic metabolism, oxidative/antioxidant balance, and inflammatory state? If so, is it beneficial or detrimental? * If this supplementation is beneficial, which dose is the most appropriate? * Do these types of supplementation have any side effects on the health of the mother and fetus? The participants will take chromium supplements for 6 weeks (supplemented groups) while the control participants will not take them (healthy and diabetic control groups).
Chromium-supplemented participants will undergo a medical check-up every 02 weeks to closely monitor their health status and detect any potential side effects at an early stage.
Researchers will compare the biochemical profile, oxidative stress status, and inflammation markers between chromium-supplemented and non-supplemented participants to assess the impact of this trace element.
Researchers will compare the effects of chromium supplements at different doses with each other.
Eligibility criteria
Qualifiers
Whose their gestational age is 28 weeks
They have no pathology or complication associated with their pregnancy.
They will be selected according to the criteria of the one-step method for screening for gestational diabetes mellitus established by the WHO.
They have no other pathology or complication associated with pregnancy.
Disqualifiers
Pregnant women with unrecognized diabetes, type I or type II, will not be involved in this study.
Pregnant women who were supplemented before one month or during pregnancy, or who will need other micronutrient supplements during the study to avoid their influence on the results.
Pregnant women who develop other health complications will be removed from the study and replaced by others.
Women with gestational diabetes mellitus who were unable to complete chromium supplementation up to 6 weeks will be excluded from the study and replaced by others.
Trial design
Treatments tested in this trial
- Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (200 µg/d)
- Dietary Supplement: Oral chromium supplementation during gestational diabetes mellitus through the administration of chromium picolinate tablets (400 µg/d)
Treatment groups
Sponsors and collaborators
University of Kasdi Merbah
Lead sponsor
Hopital Mouhamed Boudiaf, Ouergla, Algeria
Sponsor institution