Effect of Maternal Vitamin D3 Supplementation on Iron Status During Pregnancy and Early Infancy

NCT04764955 | Completed Phase 3 DMC

• 1 other identifier: 1000061108
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

This is a secondary-use study based on previously-collected data and blood samples from a previously completed double-blind, dose-ranging trial of maternal prenatal and postpartum vitamin D supplementation in Dhaka, Bangladesh (NCT01924013). The aim of this sub-study is to examine the effect of vitamin D supplementation on iron status during pregnancy and early infancy.

Conditions

Pregnancy

Keywords

Maternal Nutrition; Vitamin D; Iron Status; Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• Maternal serum ferritin concentration at delivery

  Maternal serum ferritin concentration at delivery

  Delivery

Secondary Outcomes (6)

• Maternal transferrin saturation at delivery

  Delivery

• Maternal soluble transferrin receptor at delivery

  Delivery

• Maternal circulating hepcidin at delivery

  Delivery

• Infant whole-blood Hb concentration

  6 months of age

• Infant ferritin concentration

  6 months of age

Study Arms (5)

Group A (Placebo)

PLACEBO COMPARATOR

Prenatal Period 0 IU/week (17-24 weeks gestation - delivery) ; Postpartum Period 0 IU/week (delivery-6 months postpartum)

Dietary Supplement: Placebo

Group B (4200:0 IU/week)

EXPERIMENTAL

Prenatal Period 4200 IU/week (17-24 weeks gestation - delivery) ; Postpartum Period 0 IU/week (delivery-6 months postpartum)

Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3 (cholecalciferol)

16800:0 IU/week

EXPERIMENTAL

Prenatal Period 16800 IU/week (17-24 weeks gestation - delivery) ; Postpartum Period 0 IU/week (delivery-6 months postpartum)

Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3 (cholecalciferol)

28000:0 IU/week

EXPERIMENTAL

Prenatal Period 28000 IU/week (17-24 weeks gestation - delivery) ; Postpartum Period 0 IU/week (delivery-6 months postpartum)

Dietary Supplement: Placebo; Dietary Supplement: Vitamin D3 (cholecalciferol)

28000:28000 IU/week

EXPERIMENTAL

Prenatal Period 28000 IU/week (17-24 weeks gestation - delivery) ; Postpartum Period 28000 IU/week (delivery-6 months postpartum)

Dietary Supplement: Vitamin D3 (cholecalciferol)

Interventions

Placebo DIETARY_SUPPLEMENT

This product is identical in appearance, taste and texture to the experimental formulation but does not include any vitamin D3.

16800:0 IU/week; 28000:0 IU/week; Group A (Placebo); Group B (4200:0 IU/week)

Vitamin D3 (cholecalciferol) DIETARY_SUPPLEMENT

The intervention is an oral tablet containing vitamin D3 (cholecalciferol). Each weekly dose consists of a single tablet. Vitamin D3 content of the dose depends on the intervention group.

16800:0 IU/week; 28000:0 IU/week; 28000:28000 IU/week; Group B (4200:0 IU/week)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years and above.
• Gestational age of 17 to 24 completed weeks estimated based on recalled last menstrual period (LMP) and/or ultrasound.
• Intends to permanently reside in the trial catchment area for at least 18 months
• MDIG trial participants with availability of at least one measurement of the biomarkers of interest (serum ferritin, circulating hepcidin, transferrin, soluble transferrin receptor, serum iron and/or whole-blood Hb).

You may not qualify if:

• History of medical conditions that may predispose the participant to vitamin D sensitivity, altered vitamin D metabolism and/or hypercalcemia, or history of renal calculi.
• High-risk pregnancy based on one or more of the following findings by point-of-care testing:
• \- Severe anemia: hemoglobin \<70 g/L assessed by Hemocue.
• \- Moderate-severe proteinuria: ≥ 300 mg/dl (3+ or 4+) based on urine dipstick.
• \- Hypertension: systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg.
• \- Multiple gestation, major congenital anomaly, or severe oligohydramnios based on maternal history and/or ultrasound.
• \- Unwillingness to stop taking non-study vitamin D or calcium supplements or a multivitamin with calcium and/or vitamin D.
• \- Currently prescribed vitamin D supplements as part of a physician's treatment plan for vitamin D deficiency.
• \- Previous participation in the same study.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Bill and Melinda Gates Foundation: collaborator
• King's College London: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Links

• Primary trial registration (MDIG)

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Daniel E Roth, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: March 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

BA (1)