Encapsulated Calcium Absorption in Pregnancy (ENCAP)

The Hospital for Sick Children

Status and phase: Completed; Phase 1

Conditions: Pregnancy

Treatments: Dietary Supplement: Encapsulated Calcium; Dietary Supplement: Non-capsulated Calcium

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01678079

1000033463

Details and patient eligibility

About

This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka, Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg, 1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests, one with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium and the other with a micronutrient supplement powder containing encapsulated calcium at the same dose. The absorption tests will be separated by a 2-week washout period. Fractional calcium absorption will be measured using the dual stable isotope method. For each test, the formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable isotope will be given orally and a 42Ca-labeled stable isotope dose will be given intravenously. Urine will be collected for 48 hours to measure calcium absorption.

Enrollment: 61 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 18 to 30 years
• Current residence in Dhaka at a fixed address
• Plan to remain in Dhaka for at least 2 months from date of enrolment
• Gestational age of 27 completed weeks ± 1 week, estimated based on the recalled first day of the last menstrual period (LMP)

Exclusion criteria

• Complicated medical or obstetric history, based on self-report or clinical assessment by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa, threatened abortion, hypertension, preeclampsia, multiple gestation, diabetes, renal disease)

• Higher risk pregnancy based on one or more of the following clinical findings at time of recruitment:

  • Severe anemia (hemoglobin <70 g/L assessed by Hemocue)
  • Proteinuria (≥ 100 mg/dl based on urine dipstick)
  • Glycosuria (≥ 100 mg/dl based on urine dipstick)
  • Hypertension (systolic blood pressure, ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg)

• Reported use of dietary supplements that contain >500 mg of calcium per day and/or >400 IU (10 mcg) of vitamin D per day

• Reported use (chewing) of betel leaf, areca nut and lime (together referred to locally as paan) during pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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61 participants in 6 patient groups

Micronutrient Powder, Enteric-coated Calcium (500 mg/day)

Experimental group

Description:

Encapsulated Calcium

Treatment:

Dietary Supplement: Encapsulated Calcium

Micronutrient Powder, Enteric-coated Calcium (1000 mg/day)

Experimental group

Description:

Encapsulated Calcium

Treatment:

Dietary Supplement: Encapsulated Calcium

Micronutrient Powder, Enteric-coated Calcium (1500 mg/day)

Experimental group

Description:

Encapsulated Calcium

Treatment:

Dietary Supplement: Encapsulated Calcium

Micronutrient Powder, Uncoated Calcium (500 mg/day)

Active Comparator group

Description:

Non-capsulated Calcium

Treatment:

Dietary Supplement: Non-capsulated Calcium

Micronutrient Powder, Uncoated Calcium (1000 mg/day)

Active Comparator group

Description:

Non-capsulated Calcium

Treatment:

Dietary Supplement: Non-capsulated Calcium

Micronutrient Powder, Uncoated Calcium (1500 mg/day)

Active Comparator group

Description:

Non-capsulated Calcium

Treatment:

Dietary Supplement: Non-capsulated Calcium