ISRCTN12033893
Active, not recruiting
Phase 3
Calcium supplementation for Prevention of Pre-Eclampsia in high-risk women (CaPE)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Prevention of pre-eclampsia in women at increased risk
- Sponsor
- niversity of Birmingham
- Enrollment
- 7756
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Over 16 years of age
- •2\. Able to provide informed consent to participate
- •3\. After a dating scan has confirmed viability (usually between 10 and 14 weeks gestation)
- •4\. 22 weeks’ 0 days gestation or less
- •5\. Women deemed eligible for aspirin therapy based on NICE guideline criteria below where a woman has either:
- •5\.1\. One high\-risk factor:
- •5\.1\.1\. Hypertensive disease during a previous pregnancy
- •5\.1\.2\. Chronic renal disease
- •5\.1\.3\. Autoimmune disease such as SLE or antiphospholipid syndrome
- •5\.1\.4\. Type 1 or 2 diabetes
Exclusion Criteria
- •1\. Any known contraindications to regular calcium intake (history of renal stones, known renal impairment with pre\-pregnancy eGFR \<30 ml/min/1\.73m² or serum creatinine \>150 (µmol/l), known history of hypercalcaemia or hypercalcaemia\-causing diseases (e.g. parathyroid disease, sarcoidosis, malignancy), current severe persistent vomiting leading to dehydration or requiring hospitalisation (if persisting vomiting resolves, the patient may be re\-assessed for inclusion in the trial, providing all other inclusion and exclusion criteria are met)
- •2\. Use of drugs with potential for severe interactions with calcium: digoxin or other cardiac glycosides; antiretroviral drugs for HIV treatment, anti\-neoplastic drugs, and diuretics (thiazide, thiazide\-like or xipamide).
- •3\. Use of any additional calcium supplement either on its own or as part of other multivitamin or Vitamin D preparations, and unwilling to stop them or change to other multivitamins, as this could lead to higher doses of calcium supplementation in the calcium group and contamination in the placebo group
- •4\. Women who are taking vitamin D regularly in high doses \>1000 IU/day, as supplements or for conditions such as malabsorption syndromes. Note: a short course of high dose Vitamin D (e.g., 20,000 IU weekly for 6 weeks) to treat Vitamin D deficiency during pregnancy is NOT an exclusion criteria
- •5\. Known contraindications to excipient Isomalt (e.g. hereditary fructose intolerance)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
SUPPLEMENTATION WITH CALCIUM FOR THE PREVENTION OF PRE-ECLAMPSIA IN WOMEN WITH LOW CALCIUM INTAKE-O149 Pre-eclampsia, unspecifiedPre-eclampsia, unspecifiedO149PER-013-02INSTITUTO DE INVESTIGACION NUTRICIONAL,
Not yet recruiting
Not Applicable
se of calcium carbonate supplementation to prevent Pre-eclampsia in pregnant women high risk:randomized clinical trialnspecified pre-eclampsiaC12.050.703.634RBR-7hqhj3yCentro de Ciências Biológicas e da Saúde - Universidade Federal de Sergipe
Completed
Not Applicable
Vitamin D supplementation for childreCTRI/2018/02/012187Indian Council of Medical Research ICMR300
Completed
Not Applicable
The Effect of Calcium Supplementation on Premenstrual Syndrome of Female studentsSymptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified.Symptoms and signs involving cognition, perception, emotional state and behaviourR40-R46IRCT201309296888N4Hamadan University of Medical Sciences, Department of Research and Technology (Prim64
Completed
Phase 3
Calcium for Pre-Eclampsia Prevention (CPEP)Cardiovascular DiseasesEclampsiaHeart DiseasesHELLP SyndromeHypertensionPre-EclampsiaPregnancy ToxemiasVascular DiseasesNCT00000534Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)