Trial of Calcium for Preeclampsia Prevention (CPEP): Rationale, design, and methods

Richard J. Levine, Joy R. Esterlitz, Elizabeth G. Raymond, Rebecca DerSimonian, John C. Hauth, L. Ben Curet, Baha M. Sibai, Patrick M. Catalano, Cynthia Morris, John D. Clemens, Marian G. Ewell, Steven A. Friedman, Robert L. Goldenberg, Sig Linda Jacobson, Gary M. Joffe, Mark A. Klebanoff, Alice S. Petrulis, Jose G. Rigau-Perez

Research output: Contribution to journalArticle

52 Citations (Scopus)

Abstract

The results of ten clinical trials suggest that supplemental calcium may prevent preeclampsia. However, methodologic problems and differences in study design limit the acceptance of the results and their relevance to other patient populations. Many of the trials were conducted in countries where, unlike the United States, the usual daily diet contained little calcium. Moreover, none of the trials has reported the outcome of systematic surveillance for urolithiasis, a potential complication of calcium supplementation. In response to the need for a thorough evaluation of the effects of calcium supplementation for the prevention of preeclampsia in the United States, the trial of Calcium for Preeclampsia Prevention (CPEP) was undertaken at five university medical centers. Healthy nulliparous patients were randomly assigned to receive either 2 g supplemental calcium daily (n = 2295) or placebo (n = 2294) in a double-blind study. Study tablets were administered beginning from 13 to 21 completed weeks of gestation and continued until the termination of pregnancy. CPEP employed detailed diagnostic criteria, standardized techniques of measurement, and systematic surveillance for the major study endpoints and for urolithiasis. The nutrient intake of each patient was assessed at randomization and at 32-33 weeks gestation. This report describes the study rationale, design, and methods.

Original languageEnglish (US)
Pages (from-to)442-469
Number of pages28
JournalControlled Clinical Trials
Volume17
Issue number5
DOIs
StatePublished - Oct 1996

Fingerprint

Pre-Eclampsia
Calcium
Urolithiasis
Pregnancy
Random Allocation
Double-Blind Method
Tablets
Placebos
Clinical Trials
Diet
Food
Population

Keywords

  • calcium
  • clinical trial
  • hypertension
  • preeclampsia
  • pregnancy
  • proteinuria

ASJC Scopus subject areas

  • Pharmacology

Cite this

Levine, R. J., Esterlitz, J. R., Raymond, E. G., DerSimonian, R., Hauth, J. C., Curet, L. B., ... Rigau-Perez, J. G. (1996). Trial of Calcium for Preeclampsia Prevention (CPEP): Rationale, design, and methods. Controlled Clinical Trials, 17(5), 442-469. https://doi.org/10.1016/S0197-2456(96)00106-7

Trial of Calcium for Preeclampsia Prevention (CPEP) : Rationale, design, and methods. / Levine, Richard J.; Esterlitz, Joy R.; Raymond, Elizabeth G.; DerSimonian, Rebecca; Hauth, John C.; Curet, L. Ben; Sibai, Baha M.; Catalano, Patrick M.; Morris, Cynthia; Clemens, John D.; Ewell, Marian G.; Friedman, Steven A.; Goldenberg, Robert L.; Jacobson, Sig Linda; Joffe, Gary M.; Klebanoff, Mark A.; Petrulis, Alice S.; Rigau-Perez, Jose G.

In: Controlled Clinical Trials, Vol. 17, No. 5, 10.1996, p. 442-469.

Research output: Contribution to journalArticle

Levine, RJ, Esterlitz, JR, Raymond, EG, DerSimonian, R, Hauth, JC, Curet, LB, Sibai, BM, Catalano, PM, Morris, C, Clemens, JD, Ewell, MG, Friedman, SA, Goldenberg, RL, Jacobson, SL, Joffe, GM, Klebanoff, MA, Petrulis, AS & Rigau-Perez, JG 1996, 'Trial of Calcium for Preeclampsia Prevention (CPEP): Rationale, design, and methods', Controlled Clinical Trials, vol. 17, no. 5, pp. 442-469. https://doi.org/10.1016/S0197-2456(96)00106-7
Levine RJ, Esterlitz JR, Raymond EG, DerSimonian R, Hauth JC, Curet LB et al. Trial of Calcium for Preeclampsia Prevention (CPEP): Rationale, design, and methods. Controlled Clinical Trials. 1996 Oct;17(5):442-469. https://doi.org/10.1016/S0197-2456(96)00106-7
Levine, Richard J. ; Esterlitz, Joy R. ; Raymond, Elizabeth G. ; DerSimonian, Rebecca ; Hauth, John C. ; Curet, L. Ben ; Sibai, Baha M. ; Catalano, Patrick M. ; Morris, Cynthia ; Clemens, John D. ; Ewell, Marian G. ; Friedman, Steven A. ; Goldenberg, Robert L. ; Jacobson, Sig Linda ; Joffe, Gary M. ; Klebanoff, Mark A. ; Petrulis, Alice S. ; Rigau-Perez, Jose G. / Trial of Calcium for Preeclampsia Prevention (CPEP) : Rationale, design, and methods. In: Controlled Clinical Trials. 1996 ; Vol. 17, No. 5. pp. 442-469.
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