A Randomized Controlled Study to Evaluate the Efficacy of Quadruple Fortified Salt (Iron, Iodine, Folic Acid, and Vitamin B12) in Improving Anaemia and Micronutrient Status among Early Adolescent, Women of Reproductive age, and Women aged 50 and above in Southern India: Salt Fortification for Nutritional Enhancement and Hematologic Advancement (SNEHA) Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
This study is a randomized double blind two by two factorial controlled trial designed to evaluate the efficacy of micronutrient fortified salt on nutritional status among females in Southern India. The trial will assess the effects of salt fortified with iodine and iron with or without folic acid and vitamin B12 on haemoglobin concentration red blood cell folate concentration and serum total vitamin B12 concentration.
A total of 1000 eligible female participants will be enrolled from rural households in Andhra Pradesh India. The study population includes early adolescent girls aged 10 to 14 years women of reproductive age aged 15 to 49 years and women aged 50 years and above. One eligible woman aged 15 to 49 years per household will be randomly selected as the index participant for primary intention to treat analyses. Participants and investigators will remain blinded to treatment allocation throughout the study period. Fortified salt will be distributed monthly for household consumption for a duration of 12 months.
The primary objective is to determine whether consumption of fortified salt improves haemoglobin red blood cell folate and vitamin B12 concentrations at 12 months compared with baseline among women of reproductive age. Secondary outcomes include the prevalence of anaemia folate deficiency and vitamin B12 deficiency. The study hypothesis is that fortified salt containing folic acid and vitamin B12 in addition to iron and iodine will significantly improve micronutrient status among females across the life course in the study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Early adolescent girls (10-14 years), women of reproductive age group (15-49 years) and women aged 50 years and above Healthy (defined further below under exclusion criteria) Not pregnant or lactating Plan to reside within the study area for at least two years.
排除标准
- •Severe anaemia (Haemoglobin less than 8.0 g/dL) Reported diagnosis of HIV, malaria infection, or active tuberculosis disease Malabsorption disorders (e.g., inflammatory bowel disease; i.e., medical conditions that may affect vitamin B12 absorption or metabolism) Stage 2 hypertension (i.e., systolic blood pressure (SBP) more than equal to 140 mm Hg or diastolic blood pressure (DBP) more than equal to 90 mm Hg) Glycated haemoglobin (HbA1c) more than equal to 6.5% Other serious pre-existing medical conditions (i.e., defined as the need for regular medication use), including diabetes, chronic kidney disease, cardiovascular disease, and thyroid disease Active infections or acute illnesses (e.g., fever, malaria, dengue, blood in stool) Previous pregnancy affected by a neural tube defect (i.e., who have had a foetus diagnosed as affected by a neural tube defect or have given birth to a baby with a neural tube defect) (will be referred to OB/GYN for standard of care, including folic acid supplementation, and excluded) Planning to become pregnant (or planning to have a child) in the next 12 months (will be referred to OB/GYN for standard of care, including folic acid supplementation, and be excluded) Taking daily (more than or equal to 4 times in the past week) micronutrient supplements (i.e., tablets, capsules, dispersible tablets) Received an intramuscular or intravenous intervention containing medications or micronutrients (e.g., iron, vitamin B12, folic acid) in the past 3 months.
研究者
Dr N Samarasimha Reddy
ICMR- National Institute of Nutrition