Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005206 |
| Other study ID # |
1085 |
| Secondary ID |
R01HL040005 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
February 17, 2016 |
| Start date |
September 1987 |
| Est. completion date |
August 1991 |
Study information
| Verified date |
April 2002 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To determine if low dietary calcium intake and disturbances in maternal calcium metabolism
were associated with increases in blood pressure in late pregnancy.
Description:
BACKGROUND:
The importance of maintaining dietary calcium intake and normal calcium metabolism for
optimal regulation of arterial blood pressure has been demonstrated in humans and animals.
Recent reports have suggested that low dietary calcium intake and disturbances in maternal
calcium metabolism are associated with increases in blood pressure in late gestation. These
factors may be associated with an increased risk of developing pregnancy-induced
hypertension.
This study was conducted in response to a Request for Applications on Research on
Hypertension in Pregnancy jointly released in 1986 by the National Heart, Lung, and Blood
Institute and the National Institute of Child Health and Human Development.
DESIGN NARRATIVE:
Blood pressure, nutrient intake, and markers of calcium metabolism were prospectively
assessed in normal, pregnant women. Nutrient intakes, including dietary calcium, were
assessed during gestation weeks 24, 28, 32, 36, and the postpartum period using 3-day food
records and 24-hour dietary recalls. Concomitantly, serum measures of calcium metabolism
were assessed including serum total and ionized calcium, parathyroid hormone, calcitonin,
vitamin D concentration, serum magnesium, phosphorus, sodium, and potassium concentrations.
During weeks 24 and 32, urinary excretion of sodium, calcium, magnesium, potassium,
phosphorus, cAMP, and creatinine were measured. Blood pressures were measured at every
prenatal visit and postpartum. Measures of infant growth and blood pressure were assessed at
1, 6, and 12 months of age to determine if maternal dietary calcium intake exerted long-term
influences on infant development and blood pressure.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
