Maternal Vitamin D for Infant Growth (MDIG) Trial

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Pregnancy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01924013

1000039072

Details and patient eligibility

About

The primary aims of this study are: 1) to determine whether maternal prenatal vitamin D3 supplementation (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) versus placebo increases or decreases infant length at 1 year of age, and 2) to determine whether maternal postpartum vitamin D3 supplementation (28,000 IU/week) versus placebo increases or decreases length at 1 year of age among infants born to women who received vitamin D 28,000 U/week during pregnancy. Infants enrolled in the study will be followed for 2 years to document the persistence of any observed effects measured at 1 year of age. This study aims to enroll 1300 pregnant women in the 2nd trimester at a maternity hospital in Dhaka. Participants will be randomized to one of three doses of vitamin D3 (4200 IU/week, 16,800 IU/week, or 28,000 IU/week) or placebo throughout pregnancy. Women in the 28,000 IU/week group will be additionally randomized to either placebo or a continuation of 28,000 IU/week for 6 months postpartum. In addition to linear length, the trial will include analyses of inflammatory and hormonal determinants of infant growth, epigenetic phenomena that affect vitamin D metabolism, and diarrheal and respiratory morbidity in the infants.

Enrollment: 1,300 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,300 participants in 5 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

Prenatal Period 0 IU; Postpartum Period 0 IU (placebo) Overall:The Prenatal Period will start at enrolment (17-24 weeks gestation) and last until delivery. The Postpartum Period will last from delivery until 6 months postpartum.

Treatment:

Dietary Supplement: Placebo

Group B

Experimental group

Description:

Prenatal Period 4,200 IU/week of vitamin D3 (=600 IU/d); Postpartum Period 0 IU/week (placebo)

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Vitamin D3 (cholecalciferol)

Group C

Experimental group

Description:

Prenatal Period 16,800 IU/week of vitamin D3 (=2,400 IU/d); Postpartum Period 0 IU/week (placebo)

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Vitamin D3 (cholecalciferol)

Group D

Experimental group

Description:

Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 0 IU/week (placebo)

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Vitamin D3 (cholecalciferol)

Group E

Experimental group

Description:

Prenatal Period 28,000 IU/week of vitamin D3 (=4,000 IU/d); Postpartum Period 28,000 IU/week(=4,000 IU/d)

Treatment:

Dietary Supplement: Vitamin D3 (cholecalciferol)