NCT01678079

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_1 pregnancy

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_1 pregnancy

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

August 30, 2012

Last Update Submit

November 17, 2014

Conditions

Pregnancy

Keywords

PregnancyMicronutrient PowderCalciumIronBangladesh

Outcome Measures

Primary Outcomes (2)

  • Fractional Calcium Absorption

    The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day).

    Fractional calcium absorption during day 10-11

  • Fractional Calcium Absorption

    The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day).

    Fractional calcium absorption during day 35-36

Secondary Outcomes (1)

  • Palatability and Acceptability

    Baseline, +10/11 days, +35/36 days

Study Arms (6)

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

EXPERIMENTAL

Encapsulated Calcium

Dietary Supplement: Encapsulated Calcium

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

EXPERIMENTAL

Encapsulated Calcium

Dietary Supplement: Encapsulated Calcium

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

EXPERIMENTAL

Encapsulated Calcium

Dietary Supplement: Encapsulated Calcium

Micronutrient Powder, Uncoated Calcium (500 mg/day)

ACTIVE COMPARATOR

Non-capsulated Calcium

Dietary Supplement: Non-capsulated Calcium

Micronutrient Powder, Uncoated Calcium (1000 mg/day)

ACTIVE COMPARATOR

Non-capsulated Calcium

Dietary Supplement: Non-capsulated Calcium

Micronutrient Powder, Uncoated Calcium (1500 mg/day)

ACTIVE COMPARATOR

Non-capsulated Calcium

Dietary Supplement: Non-capsulated Calcium

Interventions

Encapsulated CalciumDIETARY_SUPPLEMENT

The intervention is a multi-micronutrient powder containing enteric-coated calcium carbonate, in addition to ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg).

Micronutrient Powder, Enteric-coated Calcium (1000 mg/day)Micronutrient Powder, Enteric-coated Calcium (1500 mg/day)Micronutrient Powder, Enteric-coated Calcium (500 mg/day)
Non-capsulated CalciumDIETARY_SUPPLEMENT

The comparator/control intervention is a micronutrient powder containing non-coated calcium (500, 1000 or 1500 mg elemental calcium from calcium carbonate), ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg). This product will be similar in Ca dose, appearance, taste and texture to the experimental formulation but will not include the enteric-coating.

Micronutrient Powder, Uncoated Calcium (1000 mg/day)Micronutrient Powder, Uncoated Calcium (1500 mg/day)Micronutrient Powder, Uncoated Calcium (500 mg/day)

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21213, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

International Center for Diarrheal Disease Research

Dhaka, Bangladesh

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Roth DE, Pezzack B, Al Mahmud A, Abrams SA, Islam M, Aimone Phillips A, Baxter JA, Dimitris MC, Hawthorne KM, Ahmed T, Zlotkin SH. Bioavailability of enteric-coated microencapsulated calcium during pregnancy: a randomized crossover trial in Bangladesh. Am J Clin Nutr. 2014 Dec;100(6):1587-95. doi: 10.3945/ajcn.114.090621. Epub 2014 Oct 1.

    PMID: 25411294DERIVED

Study Officials

  • Daniel Roth, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

  • Stanley Zlotkin, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Paediatric Medicine

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 3, 2012

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

US(2)BA(1)CA(1)