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Low Dose Calcium to Prevent Preeclampsia (AMCAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02338687
Recruitment Status : Unknown
Verified February 2016 by Maria Regina Torloni, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : January 14, 2015
Last Update Posted : February 4, 2016
Sponsor:
Collaborators:
PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde)
FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas)
Universidade Federal do Amazonas
Information provided by (Responsible Party):
Maria Regina Torloni, Federal University of São Paulo

Brief Summary:
The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational intervention, compared to the educational intervention alone, in the prevention of preeclampsia and hypertensive disorders during pregnancy.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Hypertension, Pregnancy-Induced Dietary Calcium Deficiency Dietary Supplement: calcium Behavioral: Educational sessions Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Low Dose Calcium Supplementation to Prevent Preeclampsia: a Cluster Randomized Study
Study Start Date : October 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Active Comparator: Education
Educational sessions
Behavioral: Educational sessions
Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally
Other Name: Dietary counseling

Experimental: Education plus supplement
Educational sessions and 500 mg calcium per day
Dietary Supplement: calcium
one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)

Behavioral: Educational sessions
Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally
Other Name: Dietary counseling




Primary Outcome Measures :
  1. Preeclampsia [ Time Frame: at 20-40 weeks of pregnancy ]
    New onset of hypertension plus proteinuria after 20 weeks of pregnancy

  2. Hypertensive disorders of pregnancy [ Time Frame: at 20-40 weeks of pregnancy ]
    New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy


Secondary Outcome Measures :
  1. Mean change in dietary calcium intake [ Time Frame: at 30-36 weeks of pregnancy ]
    At baseline, participants will provide a dietary record and again in the 3rd trimester. Changes in the mean dietary calcium intake will be calculated.

  2. Hospital admission due to hypertension [ Time Frame: at 20-40 weeks of pregnancy ]
    Admission (before labor) due to hypertension

  3. Severe maternal morbidity [ Time Frame: at 20-40 weeks of pregnancy ]
    Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome

  4. Maternal mortality [ Time Frame: starting at 20 weeks up to hospital discharge ]
    any cause maternal mortality

  5. Gastrointestinal side effects of calcium [ Time Frame: at 20-40 weeks of pregnancy ]
    incidence of flatulence, obstipation or other symptoms any time up to delivery

  6. Maternal admission to Intensive Care Unit [ Time Frame: at 20-40 weeks of pregnancy ]
    admission for any cause

  7. Admission to Neonatal Intensive Care Unit [ Time Frame: from delivery to infant discharge ]
    admission for any cause

  8. Preterm birth [ Time Frame: at 20-36 weeks ]
    Delivery before 37 weeks

  9. Low birth weight [ Time Frame: at 20-40 weeks ]
    Birth weight less than 2500 g

  10. Small for gestational age infant [ Time Frame: at 20-40 weeks ]
    Birth of an infant whose weight is below the 10th percentile for gestational age



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Capacity to understand verbal and visual instructions
  • Gestational age 16 - 20 weeks
  • Live fetus

Exclusion Criteria:

  • Hyperparathyroidism or other contra-indication to calcium supplementation
  • Gastrointestinal diseases or conditions that may interfere with calcium absorption (e.g. bariatric surgery, cancer, chronic colitis)
  • Use of medications that may interfere with calcium absorption (e.g. corticosteroids, thiazides, thyroid hormones)
  • Women already taking calcium supplements or daily antacids at recruitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338687


Contacts
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Contact: Celsa da Silva Moura Souza, MsC, Professor 55 92 9116 4371 celsa22@hotmail.com
Contact: Erika Barbosa Camargo, PhD 55 11 55752970 erika.barbosacamargo@gmail.com

Locations
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Brazil
Universidade Federal do Amazonas Recruiting
Manaus, Amazonas, Brazil, 69077000
Contact: Celsa da Silva Moura Souza, Professor    55 92 91164371    celsa22@hotmail.com   
Contact: Rosana Rosana Pimentel Correia Moyses, Professor    55 92 3305-4712    rosana.pimentelcorreia@gmail.com   
Sponsors and Collaborators
Federal University of São Paulo
PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde)
FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas)
Universidade Federal do Amazonas
Investigators
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Study Chair: Maria Regina Torloni, MD, PhD Sao Paulo Federal University
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Responsible Party: Maria Regina Torloni, MD, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02338687    
Other Study ID Numbers: 528759
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Keywords provided by Maria Regina Torloni, Federal University of São Paulo:
Calcium
Dietary supplements
Hypertension, Pregnancy-Induced
Pre-Eclampsia
Nutritional education
Diet therapy
Diet records
Hospitalization
Maternal mortality
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs