1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [swetanka.prasad@manipal.edu].
   


6. For how long will this data be available start date provided 01-09-2026 and end date provided 01-09-2031?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Title:
Role of Iron Homeostasis and Vitamin D in Preeclampsia: A Case-Control Study on Biochemical, Hematological, and Placental Morphometric Changes

Study Type:
Case–control study

Study Setting & Duration:
Central Lab, Manipal–Tata Medical College, Jamshedpur; sample collection from Mercy Hospital, Jamshedpur.
Duration: 4 years

Background & Rationale:
Preeclampsia and eclampsia are major pregnancy complications linked to hypertension and proteinuria, with adverse maternal–fetal outcomes. Iron metabolism regulators (hepcidin, erythroferrone) and vitamin D may influence disease development. Limited human data exist on their roles in preeclampsia, particularly in the Jharkhand population. This study will explore biochemical markers, iron regulation, vitamin D status, and placental morphology to better understand disease pathophysiology.

Objectives:

1.     To measure BP, BMI, CBC, erythroferrone, hepcidin, ferritin, vitamin D, AST, ALT, uric acid, and proteinuria in preeclamptic women.

2.     To study the relationship between placental morphometry and iron/vitamin D levels in preeclampsia.

3.     To identify metabolic products in normotensive vs. preeclamptic pregnancies using GC–MS.

Study Population:

 Cases: Pregnant women (18–35 years) diagnosed with preeclampsia/eclampsia.

Controls: Age-matched normotensive pregnant women.

Sample Size: 216 (108 cases, 108 controls; includes 10 percent attrition).

Inclusion Criteria:

Pregnant women aged 18–35 years

Diagnosed with preeclampsia/eclampsia (cases) or normotensive (controls)

Exclusion Criteria:

Pre-existing hypertension, type 2 or gestational diabetes, multiple pregnancy

Thyrotoxicosis, connective tissue diseases, pheochromocytoma

Blood transfusion during pregnancy, unwillingness to consent, or loss to follow-up

Methods:

Sample Collection: 5 mL venous blood; urine for proteinuria.

Biochemical Analyses: ELISA for erythroferrone, hepcidin, ferritin, vitamin D; CBC; inflammatory markers; uric acid, AST, ALT.

·        Placental Morphometry: Weight, diameter, thickness, cotyledon count, surface area, and volume measurement post-delivery.

·        Metabolomics: GC–MS analysis for metabolic profiling.

Data Analysis:
SPSS v16 and GraphPad Prism 5 t-test and ANOVA p less than or equal to 0.05 significant.

Expected Outcomes & Significance:
This study will clarify how iron metabolism and vitamin D status contribute to preeclampsia pathogenesis, and their relationship with placental structural changes. Findings could guide targeted supplementation and improved maternal–fetal care strategies.